100 Drug Safety Associate jobs in India
Drug Safety Associate
Pune, Maharashtra
Tata Consultancy Services
Posted 7 days ago
Job Viewed
Job Description
TCS is hiring for PV Drug Safety !
Role: Pharmacovigilance
Work location: Pune
Experience: 1 - 5 years’ relevant experience in Pharmacovigilance
Qualification: Bpharm/ Mpharm/ BHMS/ BAMS/ BDS/ Msc (Biotechnology, Zoology)
Job Description:
*Ability to understand and analyses the complex data and performs the activities including accessing the case in Argus, code and enter data.
*Be fully competent to perform all steps within the case-handling processing.
*Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes, and procedures.
*Responsible for follow up procedures.
*Contribute to the development and implementation of new safety-related systems, processes, and procedures within the process.
*Support a performance-driven culture.
Regards,
Manisha Singh
TCS- HR
This advertiser has chosen not to accept applicants from your region.
0
Manager, Clinical and Safety Analytics
Hyderabad, Andhra Pradesh
Bristol Myers Squibb
Posted 1 day ago
Job Viewed
Job Description
**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
This position is responsible for enhancing and developing a framework related to data analytics reporting utilizing metrics collected within the Worldwide Patient Safety & PV CoE Analytics function. The Analyst will enable analytical use of the compliance data that provides insights related to productivity, efficiency, and quality to facilitate informed decision making for BMS REMS & Clinical Analytics.
**Position Responsibilities**
● Responsible for ensuring compliance with regulatory requirements, enhancing drug safety and regulatory adherence with qualitative and quantitative research projects through collaboration with data trends from cross-functional teams (Regulatory, Medical & Clinical Safety, Commercial, Brand Marketing, etc.)
● Maintain and develop programming, reporting and analytics applications in BMS environments such as Spotfire, Tableau, Excel.
● Leverage internal data systems and tools to efficiently maintain data visualization, communications and reporting processes to minimize manual data retrieving
● Utilize data analysis tools to aggregate and analyze data to make actional recommendations and answer key business questions.
● Develop, Run, and maintain reports regarding activities, outcomes, and trends and be prepared to deliver presentations to management team on a regular and ad-hoc basis
● Continually remain apprised of the constantly changing landscape of the healthcare industry and any impacts it may have to our REMS programs and reporting mechanisms
● Obtain a deep understanding of the prescriber and pharmacy operating environments through View Job Posting Details vendor and consulting interactions, stakeholder discussions, conference attendance, BMS events etc.
● Analyze key stakeholder complaints, address rapidly, and discuss with applicable functional leads to collaborate and propose impactful and realistic solutions
● Interpret and contextualize analytical findings documented by the REMS Advisor team
● Develop, Run and maintain reports and studies regarding Real world data analytics and present the outcomes to the stakeholders.
**Other tasks**
● Provide scheduled and ad-hoc reports to the leadership team as required
● Supporting Audit Activities related to BMS REMS & Clinical programs.
**Key Competency Requirements**
● Strong PowerPoint and Excel Skills
● Programming languages like SAS, SQL or Python etc.
● Strong knowledge and expertise in Tableau & and familiarity with Spotfire
● Databases (Salesforce, Postgres, Oracle, SharePoint List etc.)
● Ability to organize/curate data and see big picture from scattered pieces of information
● Analytical and strategic thinking skills required
● Familiarity and ability to navigate with Clinical and Real-world data
● Knowledge of Validation processes and associated documentation
● Excellent verbal, writing, presentation and project management skills
● Strong strategic orientation with ability to translate into operational priorities and plans
● Demonstrated ability to work on multiple projects
● Strong willingness to collaborate with cross-functional partners, flexible team member with positive attitude, friendly demeanor, ability to prioritize projects and balance competing priorities
● Confidentiality and integrity are required
● Strong work ethic a must
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R
**Updated:** :19:50.189 UTC
**Location:** Hyderabad-IN
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
This position is responsible for enhancing and developing a framework related to data analytics reporting utilizing metrics collected within the Worldwide Patient Safety & PV CoE Analytics function. The Analyst will enable analytical use of the compliance data that provides insights related to productivity, efficiency, and quality to facilitate informed decision making for BMS REMS & Clinical Analytics.
**Position Responsibilities**
● Responsible for ensuring compliance with regulatory requirements, enhancing drug safety and regulatory adherence with qualitative and quantitative research projects through collaboration with data trends from cross-functional teams (Regulatory, Medical & Clinical Safety, Commercial, Brand Marketing, etc.)
● Maintain and develop programming, reporting and analytics applications in BMS environments such as Spotfire, Tableau, Excel.
● Leverage internal data systems and tools to efficiently maintain data visualization, communications and reporting processes to minimize manual data retrieving
● Utilize data analysis tools to aggregate and analyze data to make actional recommendations and answer key business questions.
● Develop, Run, and maintain reports regarding activities, outcomes, and trends and be prepared to deliver presentations to management team on a regular and ad-hoc basis
● Continually remain apprised of the constantly changing landscape of the healthcare industry and any impacts it may have to our REMS programs and reporting mechanisms
● Obtain a deep understanding of the prescriber and pharmacy operating environments through View Job Posting Details vendor and consulting interactions, stakeholder discussions, conference attendance, BMS events etc.
● Analyze key stakeholder complaints, address rapidly, and discuss with applicable functional leads to collaborate and propose impactful and realistic solutions
● Interpret and contextualize analytical findings documented by the REMS Advisor team
● Develop, Run and maintain reports and studies regarding Real world data analytics and present the outcomes to the stakeholders.
**Other tasks**
● Provide scheduled and ad-hoc reports to the leadership team as required
● Supporting Audit Activities related to BMS REMS & Clinical programs.
**Key Competency Requirements**
● Strong PowerPoint and Excel Skills
● Programming languages like SAS, SQL or Python etc.
● Strong knowledge and expertise in Tableau & and familiarity with Spotfire
● Databases (Salesforce, Postgres, Oracle, SharePoint List etc.)
● Ability to organize/curate data and see big picture from scattered pieces of information
● Analytical and strategic thinking skills required
● Familiarity and ability to navigate with Clinical and Real-world data
● Knowledge of Validation processes and associated documentation
● Excellent verbal, writing, presentation and project management skills
● Strong strategic orientation with ability to translate into operational priorities and plans
● Demonstrated ability to work on multiple projects
● Strong willingness to collaborate with cross-functional partners, flexible team member with positive attitude, friendly demeanor, ability to prioritize projects and balance competing priorities
● Confidentiality and integrity are required
● Strong work ethic a must
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R
**Updated:** :19:50.189 UTC
**Location:** Hyderabad-IN
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
This advertiser has chosen not to accept applicants from your region.
1
Safety Specialist
Bengaluru, Karnataka
Chevron Corporation
Posted 4 days ago
Job Viewed
Job Description
**About the position:**
The Safety Specialist is responsible for providing technical support and analysis of Control of Work (CoW) activities supporting enterprise-wide activities including the development and implementation of safe work practices and standards. The Safety Specialist reports to the Workforce Safey Team Lead in the Chevron Engine in Bengaluru, India.
**Key responsibilities:**
+ Serve as a technical resource for safety matters and Safe Work Practices, ensuring compliance with regulations and industry guidance
+ Utilize IT tools for analysis of safety data and trends to identify areas of improvement to provide actionable insights to enhance workplace safety
+ Support the development and delivery of control of work (CoW) process and standards, including engagements with business units, facilitation of teams, and development of deployment materials
+ Provide support to Enterprise and Business Units including technical support for control of work, interpretation of standards, and regulations
+ Assist in developing and delivering HSE training course materials, including providing live instruction for various topics
+ Support efforts to prevent incidents with a focus on eliminating significant incidents and fatalities through providing guidance on implementation and delivery of the CoW process, standards and procedures
+ Position supports delivery of work including workforce safety focus area projects and pilots across the Enterprise
+ Support incident investigation process and provide analysis of root cause analysis and trends
+ Support for electronic Control of Work (eCoW) digital tool including development of enhancements and data analysis
**Required Qualifications:**
+ Bachelor's degree in occupational safety, engineering, or related field or equivalent work experience
+ Comprehensive Safety Knowledge: Demonstrates technical understanding and ability to apply health & safety standards and regulations pertaining to industrial workplace settings
+ Knowledge of oil & gas industry safety procedures, policies, & regulatory requirements
+ Experience with Safety Audits and Inspections: Proven experience conducting audits, field inspections, and providing interpretations of regulatory regulations, and industry standards / guidance is preferred
+ Experience in development and communicating safety procedures and conducting training for this material is preferred
+ Ability to Interpret laws/regulations or policies/best practices, develop compliance guidelines, and provide practical solutions for field implementation is preferred
+ Experience in compliance, and stakeholder engagement is preferred
+ Leadership, communication, strategic thinking, and program/project management skills are preferred
Chevron ENGINE supports global operations, supporting business requirements across the world. Accordingly, the work hours for employees will be aligned to support business requirements. The standard work week will be Monday to Friday. Working hours are 8:00am to 5:00pm or 1.30pm to 10.30pm.
Chevron participates in E-Verify in certain locations as required by law.
Chevron Corporation is one of the world's leading integrated energy companies. Through its subsidiaries that conduct business worldwide, the company is involved in virtually every facet of the energy industry. Chevron explores for, produces and transports crude oil and natural gas; refines, markets and distributes transportation fuels and lubricants; manufactures and sells petrochemicals and additives; generates power; and develops and deploys technologies that enhance business value in every aspect of the company's operations. Chevron is based in Houston, Texas. More information about Chevron is available at .
Chevron is an Equal Opportunity / Affirmative Action employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status, or other status protected by law or regulation.
The Safety Specialist is responsible for providing technical support and analysis of Control of Work (CoW) activities supporting enterprise-wide activities including the development and implementation of safe work practices and standards. The Safety Specialist reports to the Workforce Safey Team Lead in the Chevron Engine in Bengaluru, India.
**Key responsibilities:**
+ Serve as a technical resource for safety matters and Safe Work Practices, ensuring compliance with regulations and industry guidance
+ Utilize IT tools for analysis of safety data and trends to identify areas of improvement to provide actionable insights to enhance workplace safety
+ Support the development and delivery of control of work (CoW) process and standards, including engagements with business units, facilitation of teams, and development of deployment materials
+ Provide support to Enterprise and Business Units including technical support for control of work, interpretation of standards, and regulations
+ Assist in developing and delivering HSE training course materials, including providing live instruction for various topics
+ Support efforts to prevent incidents with a focus on eliminating significant incidents and fatalities through providing guidance on implementation and delivery of the CoW process, standards and procedures
+ Position supports delivery of work including workforce safety focus area projects and pilots across the Enterprise
+ Support incident investigation process and provide analysis of root cause analysis and trends
+ Support for electronic Control of Work (eCoW) digital tool including development of enhancements and data analysis
**Required Qualifications:**
+ Bachelor's degree in occupational safety, engineering, or related field or equivalent work experience
+ Comprehensive Safety Knowledge: Demonstrates technical understanding and ability to apply health & safety standards and regulations pertaining to industrial workplace settings
+ Knowledge of oil & gas industry safety procedures, policies, & regulatory requirements
+ Experience with Safety Audits and Inspections: Proven experience conducting audits, field inspections, and providing interpretations of regulatory regulations, and industry standards / guidance is preferred
+ Experience in development and communicating safety procedures and conducting training for this material is preferred
+ Ability to Interpret laws/regulations or policies/best practices, develop compliance guidelines, and provide practical solutions for field implementation is preferred
+ Experience in compliance, and stakeholder engagement is preferred
+ Leadership, communication, strategic thinking, and program/project management skills are preferred
Chevron ENGINE supports global operations, supporting business requirements across the world. Accordingly, the work hours for employees will be aligned to support business requirements. The standard work week will be Monday to Friday. Working hours are 8:00am to 5:00pm or 1.30pm to 10.30pm.
Chevron participates in E-Verify in certain locations as required by law.
Chevron Corporation is one of the world's leading integrated energy companies. Through its subsidiaries that conduct business worldwide, the company is involved in virtually every facet of the energy industry. Chevron explores for, produces and transports crude oil and natural gas; refines, markets and distributes transportation fuels and lubricants; manufactures and sells petrochemicals and additives; generates power; and develops and deploys technologies that enhance business value in every aspect of the company's operations. Chevron is based in Houston, Texas. More information about Chevron is available at .
Chevron is an Equal Opportunity / Affirmative Action employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status, or other status protected by law or regulation.
This advertiser has chosen not to accept applicants from your region.
2
Drug Safety Specialist - Japanese
Parexel
Posted 4 days ago
Job Viewed
Job Description
**Key Accountabilities** :
The below responsibilities vary as per applicable as per the job role.
**General**
+ Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client's guidelines, and SOPs, and Global drug safety regulations
+ Maintaining an awareness of global regulatory reporting obligations and organizing work to ensure compliance with internal and regulatory timelines for the adverse event reporting
+ Assist in development of project specific safety procedures, workflows and templates.
+ Attend/Conduct internal, drug safety and project specific training sessions Completes trainings assigned on internal and client Learning Management System (LMS) as applicable
+ Preparation for, participation in, and follow up on audits and inspections Maintaining an awareness of the performance metrices measured by the client and striving to remain within established limits
+ Delegate work as appropriate to Drug Safety Assistants
+ Liaising and collaborating with the relevant function at the client's end to facilitate the delivery of high-quality work
+ Identifies areas of concern and raising the issues with senior management Assist with additional Drug Safety Specialist and/or senior management in project related activities as required
+ Mentoring new recruits in the team, if required
+ Archiving the source documents and relevant emails as required
+ Responds to clients/customers in a timely manner
**Case processing**
+ Monitoring of incoming reports from various sources viz mailboxes, Eudravigilance, literature searches etc.
+ Triage of incoming reports for completeness, legibility and validity, including literature abstracts/articles/citations
+ Preform a check on overall medical cohesiveness and consistency of the document
+ Compares and analyses data provided by the affiliate with the data available on client application
+ Addition of new products/deletion of products withdrawn from the market/expired license/MAH transferred products on the client application tool
+ Creates the case on the safety database and performs Data entry into safety database
+ Performs clear and accurate data capture of cases in accordance with client conventions/guidelines and Standard Operating Procedures (SOPs)
+ Ensures that the expectedness, causality assessment and seriousness criteria are accurate for the events
+ Ensures MedDRA coding in accordance with "MedDRA Term selection: Points to Consider"
+ Request follow-up and perform query management, as applicable Prepares medically cohesive case narratives based upon the reported information
+ Routes the case to the next workflow state as applicable in the safety database Performs quality checks/validation checks
+ Perform literature searches as per search strategy, performs data entry of valid cases into the safety database
+ Case reconciliation- coordinating activities with Data Management personnel
+ Line listing and tabulation generation for safety reports i.e., periodic safety reports, ad hoc safety reports etc.
+ Supports compliance activities for ICSRs including late case investigation of ICSRs to various Health Authorities and Business Partners to determine the assignable cause for lateness and collection of lateness documentation including corrective actions, where applicable
+ Generation, reporting and reconciliation of compliance metrics in collaboration with internal and external partners and stakeholders, where applicable
**Drug Safety Reporting**
+ Quality control of case reports, line listings, and tabulations Develop Expedited Reporting Procedures
+ Maintain local drug safety reporting requirements
+ Perform registration with relevant authorities for electronic reporting on behalf of sponsor
+ Perform setup and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy)
+ Submission of safety reports to investigators via SIS (Safety Information System)
+ Tracking and filing of submission cases as required Unblinding of SUSARs, as required
+ Collect and review metrics for measuring reporting compliance
+ Work with Global PV Information Office for collection and organization of global PV requirements
**Regulatory Affairs**
+ Compares the data received from client with the information present in database for the drug applications to be remediated; identifies and updates any missing information in the database
+ Creates new applications, regulatory events, product detail set, tasks, sequences and references in database based on instructions provided by client Responsible for maintaining and tracking changes in the life cycle of a medicinal product or device such as pharmaceutical strength, packaging, manufacturing sites, storage conditions or shelf life, etc. in the regulatory database per the information received from the client.
+ Creation of variations in the regulatory database to track labeling, quality or administrative changes, creation of references for responses to health authority regarding PSUSA or PBRER, Referrals etc. in the European Union region for National, Centralized, Mutual Recognition and Decentralized procedures.
+ Creation of reports for publishing in order to dispatch the dossier to affiliates or agency (EMA) and generation of marketing authorization status reports from the database for co-ordination of PV activities.
+ Validation the data content with the latest version of SmPC and performing the xEVMPD submissions via EMA Gateway for client's products and tracking the status of submissions and acknowledgement date.
**Literature Search and review**
+ Formulate and maintain the search strategy/strategies in line with parameters provided by the client to enable accurate and exhaustive identification and retrieval of scientific and medical literature articles from the literature database for ad hoc literature requests, regulatory requests and DSUR requests Send the citations retrieved to the requestor in the specified format Records are reviewed, and valid cases are entered into the client database Identification and maintenance of local journals in scope for local literature search
+ Performing Quality Check of the developed/updated search strategies and local journals.
+ Perform periodic review of database thesauri updates and implementation of necessary changes to the search strategies in a timely manner.
+ Interacting with internal or external contacts to resolve issues relatedto literature searches
**Skills:**
+ Sound knowledge of drug safety and the drug development process
+ Knowledge of and ability to interpret and apply global safety regulations
+ Experience in data analysis and evaluation of safety data
+ Good presentation skills
+ Analytical and problem-solving skills
+ Clear understanding of the regulatory submission process
+ Proficient in database/literature searches
+ Excellent interpersonal skills
+ Excellent verbal / written communication skills
+ Excellent organizational and prioritization skills
+ Ability to work collaboratively and effectively in a team environment
+ Client focused approach to work
+ Ability to evaluate data and draw conclusions independently
+ Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
+ Computer proficiency, IT skills, the expertise and an ability to work with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point)
**Knowledge and Experience** :
+ Related experience in drug safety/ pharmacovigilance is desirable
+ Good knowledge of medical terminology
+ Excellent communication (written & spoken English + Japanese - JLPT N2 or above).
+ JLPT N2 or higher certification or equivalent
+ Experience with PMDA PV activities
+ Experience working with Japanese-speaking PV case processing teams
**Education:**
+ Degree in life Sciences, Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.), or relevant work experience in Pharmacovigilance.
+ A degree in Medicine/Dentistry/physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage.
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
The below responsibilities vary as per applicable as per the job role.
**General**
+ Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client's guidelines, and SOPs, and Global drug safety regulations
+ Maintaining an awareness of global regulatory reporting obligations and organizing work to ensure compliance with internal and regulatory timelines for the adverse event reporting
+ Assist in development of project specific safety procedures, workflows and templates.
+ Attend/Conduct internal, drug safety and project specific training sessions Completes trainings assigned on internal and client Learning Management System (LMS) as applicable
+ Preparation for, participation in, and follow up on audits and inspections Maintaining an awareness of the performance metrices measured by the client and striving to remain within established limits
+ Delegate work as appropriate to Drug Safety Assistants
+ Liaising and collaborating with the relevant function at the client's end to facilitate the delivery of high-quality work
+ Identifies areas of concern and raising the issues with senior management Assist with additional Drug Safety Specialist and/or senior management in project related activities as required
+ Mentoring new recruits in the team, if required
+ Archiving the source documents and relevant emails as required
+ Responds to clients/customers in a timely manner
**Case processing**
+ Monitoring of incoming reports from various sources viz mailboxes, Eudravigilance, literature searches etc.
+ Triage of incoming reports for completeness, legibility and validity, including literature abstracts/articles/citations
+ Preform a check on overall medical cohesiveness and consistency of the document
+ Compares and analyses data provided by the affiliate with the data available on client application
+ Addition of new products/deletion of products withdrawn from the market/expired license/MAH transferred products on the client application tool
+ Creates the case on the safety database and performs Data entry into safety database
+ Performs clear and accurate data capture of cases in accordance with client conventions/guidelines and Standard Operating Procedures (SOPs)
+ Ensures that the expectedness, causality assessment and seriousness criteria are accurate for the events
+ Ensures MedDRA coding in accordance with "MedDRA Term selection: Points to Consider"
+ Request follow-up and perform query management, as applicable Prepares medically cohesive case narratives based upon the reported information
+ Routes the case to the next workflow state as applicable in the safety database Performs quality checks/validation checks
+ Perform literature searches as per search strategy, performs data entry of valid cases into the safety database
+ Case reconciliation- coordinating activities with Data Management personnel
+ Line listing and tabulation generation for safety reports i.e., periodic safety reports, ad hoc safety reports etc.
+ Supports compliance activities for ICSRs including late case investigation of ICSRs to various Health Authorities and Business Partners to determine the assignable cause for lateness and collection of lateness documentation including corrective actions, where applicable
+ Generation, reporting and reconciliation of compliance metrics in collaboration with internal and external partners and stakeholders, where applicable
**Drug Safety Reporting**
+ Quality control of case reports, line listings, and tabulations Develop Expedited Reporting Procedures
+ Maintain local drug safety reporting requirements
+ Perform registration with relevant authorities for electronic reporting on behalf of sponsor
+ Perform setup and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy)
+ Submission of safety reports to investigators via SIS (Safety Information System)
+ Tracking and filing of submission cases as required Unblinding of SUSARs, as required
+ Collect and review metrics for measuring reporting compliance
+ Work with Global PV Information Office for collection and organization of global PV requirements
**Regulatory Affairs**
+ Compares the data received from client with the information present in database for the drug applications to be remediated; identifies and updates any missing information in the database
+ Creates new applications, regulatory events, product detail set, tasks, sequences and references in database based on instructions provided by client Responsible for maintaining and tracking changes in the life cycle of a medicinal product or device such as pharmaceutical strength, packaging, manufacturing sites, storage conditions or shelf life, etc. in the regulatory database per the information received from the client.
+ Creation of variations in the regulatory database to track labeling, quality or administrative changes, creation of references for responses to health authority regarding PSUSA or PBRER, Referrals etc. in the European Union region for National, Centralized, Mutual Recognition and Decentralized procedures.
+ Creation of reports for publishing in order to dispatch the dossier to affiliates or agency (EMA) and generation of marketing authorization status reports from the database for co-ordination of PV activities.
+ Validation the data content with the latest version of SmPC and performing the xEVMPD submissions via EMA Gateway for client's products and tracking the status of submissions and acknowledgement date.
**Literature Search and review**
+ Formulate and maintain the search strategy/strategies in line with parameters provided by the client to enable accurate and exhaustive identification and retrieval of scientific and medical literature articles from the literature database for ad hoc literature requests, regulatory requests and DSUR requests Send the citations retrieved to the requestor in the specified format Records are reviewed, and valid cases are entered into the client database Identification and maintenance of local journals in scope for local literature search
+ Performing Quality Check of the developed/updated search strategies and local journals.
+ Perform periodic review of database thesauri updates and implementation of necessary changes to the search strategies in a timely manner.
+ Interacting with internal or external contacts to resolve issues relatedto literature searches
**Skills:**
+ Sound knowledge of drug safety and the drug development process
+ Knowledge of and ability to interpret and apply global safety regulations
+ Experience in data analysis and evaluation of safety data
+ Good presentation skills
+ Analytical and problem-solving skills
+ Clear understanding of the regulatory submission process
+ Proficient in database/literature searches
+ Excellent interpersonal skills
+ Excellent verbal / written communication skills
+ Excellent organizational and prioritization skills
+ Ability to work collaboratively and effectively in a team environment
+ Client focused approach to work
+ Ability to evaluate data and draw conclusions independently
+ Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
+ Computer proficiency, IT skills, the expertise and an ability to work with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point)
**Knowledge and Experience** :
+ Related experience in drug safety/ pharmacovigilance is desirable
+ Good knowledge of medical terminology
+ Excellent communication (written & spoken English + Japanese - JLPT N2 or above).
+ JLPT N2 or higher certification or equivalent
+ Experience with PMDA PV activities
+ Experience working with Japanese-speaking PV case processing teams
**Education:**
+ Degree in life Sciences, Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.), or relevant work experience in Pharmacovigilance.
+ A degree in Medicine/Dentistry/physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage.
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
This advertiser has chosen not to accept applicants from your region.
3
Environmental Health Safety Specialist
Pune, Maharashtra
LTIMindtree
Posted 7 days ago
Job Viewed
Job Description
About the Company : LTI Mindtree is committed to fostering a culture of innovation and excellence in the field of Environmental Health and Safety (EHS). Our mission is to provide sustainable solutions that meet the evolving needs of our clients while ensuring compliance with global regulations.
About the Role : We are seeking an EHS Domain Lead/Specialist to partner with business EHS, HSE Compliance, and Sustainability teams. This role will involve capturing requirements and mapping them to capabilities in various EHS platforms.
Responsibilities :
- Partner with business EHS, HSE Compliance, and Sustainability to capture requirements and map to capabilities in EHS platforms (e.g., 3E, ENHESA, IntelexMST, IUCLID6, DEKRA, BBS, SAFER ONE, SafeTK, SAP, VHPESS).
- Lead solution design for change requests, enhancements, workflows, forms, dashboards, and reporting.
- Interpret global/regional EHS regulations (REACH, CLP, GHS, OSHA, EPA, etc.) and align systems accordingly.
- Define and maintain data models, taxonomies, and master/reference data governance.
- Own integration requirements with SAP, SSO, and data feeds.
- Create functional specs, test scenarios, and UAT scripts; support training and change management.
- Serve as escalation point for complex incidents; drive RCA and preventive actions.
- Ensure adherence to export control and data privacy requirements.
Qualifications :
- Bachelor's or Master's degree in Environmental Science, Engineering, or related field.
- Professional EHS certifications (CSP, CIH, NEBOSH) preferred.
- Experience: 7-10 years in EHS domain; 5 years implementing/supporting EHS/Compliance applications (at least two among IntelexMST, 3E, ENHESA, IUCLID, DEKRA, BBS, SAFER ONE).
Required Skills :
- Hands-on configuration experience in at least one core EHS platform.
- Working knowledge of SAP integration touchpoints.
- Understanding of SSO/SAML/OAuth, data privacy, and global deployment governance.
- Exposure to SAFER ONE, SafeTK, IATA workflows.
Preferred Skills :
- Strong understanding of EHS processes (incident, risk, audits, actions, change management, chemical management, compliance, emissions).
- Ability to interpret global/regional EHS regulations and translate into system configurations.
- Experience in stakeholder management and cross-functional collaboration.
- Knowledge of export control and data privacy compliance.
Pay range and compensation package : Competitive salary based on experience.
Equal Opportunity Statement : LTI Mindtree is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Interested candidates, please share resumes on
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4
Environmental Health Safety Specialist
Gurgaon Rural, Haryana
V-Guard
Posted 7 days ago
Job Viewed
Job Description
Job Profile:
Post : Asst. Mgr./Deputy Manager (EHS)
Base Location: Cochin – Corp. Office or Gurgaon
Job Location: Multiple Unit locations in India. Experience as a safety head with a
responsibility of handling a multi-location plants shall be an added advantage.
Job Category – Preparation and Implementation of EHS standards and obtaining ISO
certifications (ISO 45001:2018 & ISO 14001:2015) in all V-Guard operations (Manufacturing,
Corp.office & Warehouse). Implementing Sustainability initiatives across all operations and
preparation of BRSR report. Conducting audits & assessment and training across V-Guard
operations.
Qualification and Other Requirements:
1. Qualification: Any Graduate Engineer and Industrial safety from reputed institute.
2. Lead auditor in ISO 14001:2015 and ISO 45001:2018
3. Experience: 08 to 12 Years in the field of Environment Health & Safety from reputed
organizations
4. Age: Between – 35 to 40.
5. Language : English & Hindi
Job Description:
1. Preparation of EHS manual (EHSM) in coordination with Unit level Management Representatives.
2. Developing and Monitoring Implementation of SOPs.
3. Conduct EHSMS audit.
4. Develop safe work procedure for contract workmen and its effective implementation.
5. Formulation, Implementation, Review & up dations of Occupational Health, Safety & Environment Management system in order to achieve objective set by EHS Policy.
6. Preparing & updation of On-site plan Co-ordination, Set-up of emergency organization, Mock Drill and rehearsal.
7. Manage MIS reporting.
8. Enabling EHS Management system in all Manufacturing locations and warehouse operations.
9. Co-ordinate with certification body for surveillance audit and re-certification audit.
10. Conducting training programme to all functional heads with respective of EHS Management system.
11. Conducting Internal audits periodically in all Manufacturing locations.
12. Ensuring the status of audit Non-conformities and observations conducted by various agencies.
13. Conducting EHS events at Corporate office like Safety day celebration, World Environment day celebration.
14. Co-ordinating with Corp. office Management Representative.
15. Implementing EHS initiatives at Corp. office.
16. To co-operate with Unit Management Representative for the implementation of EMS & OHSMS requirements.
17. Preparation of BRSR report and data collection from various locations.
18. Conducting training programme at all Units.
19. Preparing V-Guard protocol, Standards, procedures and monitoring the effectiveness of the standards.
20. Preparing Training videos, Toolbox talks and conducting events at corporate level to
promote EHS culture
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5
Environmental Health & Safety Specialist
641001 Coimbatore, Tamil Nadu
₹55000 Annually
WhatJobs
Posted 14 days ago
Job Viewed
Job Description
Our client is looking for a dedicated and meticulous Environmental Health & Safety (EHS) Specialist to join our operations team in Coimbatore, Tamil Nadu . This position is crucial for ensuring a safe and healthy working environment for all employees and maintaining compliance with all environmental regulations. The ideal candidate will have a strong background in EHS protocols, risk assessment, and incident investigation, coupled with a proactive approach to safety management. You will be responsible for developing, implementing, and monitoring EHS policies and procedures across our facilities.
Key responsibilities include conducting regular safety audits and inspections, identifying potential hazards, and recommending corrective actions. You will be involved in developing and delivering EHS training programs to employees at all levels. This role also requires managing incident reporting and investigation processes, ensuring thorough root cause analysis and implementation of preventive measures. You will stay abreast of all local, state, and national environmental and safety regulations, ensuring our organization remains compliant and minimizes its environmental impact. Collaboration with departmental managers to integrate safety into daily operations and foster a strong safety culture is essential. Experience in waste management, hazardous material handling, and emergency preparedness planning is highly valued. The successful candidate will be proficient in documentation and record-keeping, maintaining accurate EHS records.
Qualifications:
Key responsibilities include conducting regular safety audits and inspections, identifying potential hazards, and recommending corrective actions. You will be involved in developing and delivering EHS training programs to employees at all levels. This role also requires managing incident reporting and investigation processes, ensuring thorough root cause analysis and implementation of preventive measures. You will stay abreast of all local, state, and national environmental and safety regulations, ensuring our organization remains compliant and minimizes its environmental impact. Collaboration with departmental managers to integrate safety into daily operations and foster a strong safety culture is essential. Experience in waste management, hazardous material handling, and emergency preparedness planning is highly valued. The successful candidate will be proficient in documentation and record-keeping, maintaining accurate EHS records.
Qualifications:
- Bachelor's degree in Environmental Science, Occupational Health and Safety, Engineering, or a related field.
- 3-5 years of experience in EHS roles.
- Knowledge of OSHA, EPA, and other relevant safety and environmental regulations.
- Experience in conducting risk assessments and safety audits.
- Strong understanding of industrial hygiene principles.
- Excellent communication, training, and interpersonal skills.
- Ability to work independently and as part of a team.
- Proficiency in Microsoft Office Suite and EHS management software.
- Certification such as CSP or CIH is a plus.
- Willingness to work a hybrid schedule, balancing on-site presence with remote tasks.
This advertiser has chosen not to accept applicants from your region.
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6
Industrial Hygiene & Safety Specialist
208001 Kanpur, Uttar Pradesh
₹65000 Monthly
WhatJobs
Posted 14 days ago
Job Viewed
Job Description
Our client is seeking a dedicated and knowledgeable Industrial Hygiene & Safety Specialist to join their team. This position is crucial for ensuring a safe and healthy working environment across all company facilities. The role involves assessing workplace hazards, developing and implementing safety protocols, conducting training, and ensuring compliance with relevant health and safety regulations. The ideal candidate will have a strong understanding of industrial hygiene principles and a proactive approach to risk management.
Key Responsibilities:
Qualifications:
This is a vital role in protecting the well-being of employees and ensuring regulatory compliance. The position is based in Kanpur, Uttar Pradesh, IN . If you are a dedicated safety professional committed to creating a secure work environment, we encourage you to apply.
Key Responsibilities:
- Conduct regular workplace inspections and risk assessments to identify potential health and safety hazards.
- Develop, implement, and manage comprehensive industrial hygiene and safety programs.
- Monitor and evaluate employee exposure to chemical, physical, and biological agents.
- Recommend and implement control measures to mitigate identified hazards.
- Develop and deliver safety training programs to employees at all levels.
- Ensure compliance with all relevant local, state, and national health and safety regulations (e.g., OSHA).
- Investigate workplace accidents, incidents, and near misses, identifying root causes and recommending corrective actions.
- Maintain detailed records of inspections, training, incident reports, and safety data sheets (SDS).
- Develop and update emergency preparedness and response plans.
- Collaborate with management and employees to foster a strong safety culture.
- Stay current with advancements in industrial hygiene and safety practices and regulations.
- Conduct periodic audits to ensure the effectiveness of safety programs.
- Manage and coordinate with external safety consultants and regulatory agencies as needed.
Qualifications:
- Bachelor's degree in Industrial Hygiene, Occupational Safety and Health, Environmental Science, or a related field.
- Minimum of 4 years of experience in industrial hygiene and safety management.
- Knowledge of relevant safety regulations and standards (e.g., OSHA).
- Experience with hazard identification, risk assessment, and control measures.
- Strong understanding of chemical safety, noise monitoring, ergonomics, and ventilation systems.
- Excellent communication, training, and interpersonal skills.
- Ability to conduct thorough investigations and develop effective action plans.
- Proficiency in safety management software and Microsoft Office Suite.
- Ability to work independently and collaboratively with cross-functional teams.
- Professional certifications such as CIH (Certified Industrial Hygienist) or CSP (Certified Safety Professional) are highly desirable.
This is a vital role in protecting the well-being of employees and ensuring regulatory compliance. The position is based in Kanpur, Uttar Pradesh, IN . If you are a dedicated safety professional committed to creating a secure work environment, we encourage you to apply.
This advertiser has chosen not to accept applicants from your region.
7
Industrial Hygiene & Safety Specialist
800001 Patna, Bihar
₹75000 Monthly
WhatJobs
Posted 14 days ago
Job Viewed
Job Description
Our client, a prominent manufacturing facility, is seeking a highly qualified Industrial Hygiene & Safety Specialist to join their operational team in Patna, Bihar . This role is crucial for ensuring a safe and healthy working environment for all employees by implementing and managing comprehensive safety programs and industrial hygiene protocols. The ideal candidate will possess a strong understanding of occupational safety regulations, hazard assessment, risk management, and relevant industry best practices. You will be responsible for conducting workplace safety inspections, identifying potential hazards, developing corrective action plans, and ensuring compliance with all legal and company safety standards. This position requires hands-on experience in monitoring workplace exposures to chemical, physical, and biological agents, and recommending appropriate control measures. You will also play a key role in developing and delivering safety training programs to employees at all levels. The successful applicant will have excellent observational skills, strong analytical abilities, and the capacity to effectively communicate safety information and recommendations. Prior experience in a manufacturing or industrial setting is essential. This is an excellent opportunity for a dedicated safety professional to contribute to a culture of safety and well-being within a respected organization. You will work closely with management and employees to foster a proactive safety mindset and continuously improve safety performance.
Key Responsibilities:
Key Responsibilities:
- Develop, implement, and manage comprehensive industrial hygiene and safety programs.
- Conduct regular workplace safety inspections and hazard assessments.
- Identify potential safety risks and recommend appropriate control measures.
- Monitor workplace exposures to chemical, physical, and biological agents.
- Develop and implement strategies to mitigate identified risks.
- Ensure compliance with all relevant national and local safety regulations (e.g., OSHA equivalents).
- Investigate incidents, accidents, and near misses, and recommend corrective actions.
- Develop and deliver engaging safety training programs for employees.
- Maintain accurate safety records and documentation.
- Collaborate with management and employees to promote a strong safety culture.
- Conduct ergonomic assessments and recommend improvements.
- Oversee the proper use and maintenance of safety equipment.
- Stay updated on the latest developments and best practices in industrial hygiene and safety.
- Bachelor's degree in Occupational Health and Safety, Industrial Hygiene, Environmental Science, Engineering, or a related field.
- Minimum of 5 years of experience in industrial hygiene and safety management, preferably in a manufacturing environment.
- In-depth knowledge of hazard recognition, risk assessment, and control strategies.
- Familiarity with relevant safety regulations and standards.
- Experience with industrial hygiene monitoring techniques and equipment.
- Strong analytical and problem-solving skills.
- Excellent communication, presentation, and training skills.
- Proficiency in safety management systems and software.
- Ability to work independently and collaboratively.
- Professional certifications (e.g., CIH, CSP) are highly desirable.
This advertiser has chosen not to accept applicants from your region.
8
Remote Aviation Safety Specialist
600001 Chennai, Tamil Nadu
₹700000 Annually
WhatJobs
Posted 25 days ago
Job Viewed
Job Description
Our client is seeking a highly qualified and dedicated Remote Aviation Safety Specialist to contribute to maintaining the highest standards of safety within the aviation industry. This is a fully remote position, allowing you to apply your expertise from anywhere, supporting critical safety initiatives. The ideal candidate will possess a deep understanding of aviation regulations, safety management systems (SMS), and risk assessment methodologies. You will be responsible for developing, implementing, and monitoring safety programs to prevent accidents and ensure regulatory compliance.
Key responsibilities include conducting thorough safety audits and risk assessments of aviation operations, identifying potential hazards, and recommending corrective actions. You will analyze safety data, accident/incident reports, and trend analysis to proactively address safety concerns. The Remote Aviation Safety Specialist will also play a crucial role in developing and delivering safety training materials to flight crews, ground staff, and other personnel. You will be involved in the continuous improvement of the organization's Safety Management System (SMS), ensuring it meets or exceeds regulatory requirements set by aviation authorities. Collaboration with various departments, including operations, maintenance, and training, will be essential to foster a strong safety culture throughout the organization. You will maintain detailed records and prepare comprehensive safety reports.
We require a Bachelor's degree in Aviation Management, Aerospace Engineering, or a related field, along with a minimum of 5 years of experience in aviation safety, regulatory compliance, or risk management. Proven knowledge of ICAO, EASA, or FAA regulations is essential. Certifications such as Certified Aviation Safety Officer (CASO) or equivalent are highly desirable. Excellent analytical, problem-solving, and investigative skills are critical. Strong communication and presentation skills are necessary to effectively convey safety information and training across virtual platforms. This remote role offers a significant opportunity for safety professionals to make a tangible impact on aviation safety from a flexible work environment.
Key responsibilities include conducting thorough safety audits and risk assessments of aviation operations, identifying potential hazards, and recommending corrective actions. You will analyze safety data, accident/incident reports, and trend analysis to proactively address safety concerns. The Remote Aviation Safety Specialist will also play a crucial role in developing and delivering safety training materials to flight crews, ground staff, and other personnel. You will be involved in the continuous improvement of the organization's Safety Management System (SMS), ensuring it meets or exceeds regulatory requirements set by aviation authorities. Collaboration with various departments, including operations, maintenance, and training, will be essential to foster a strong safety culture throughout the organization. You will maintain detailed records and prepare comprehensive safety reports.
We require a Bachelor's degree in Aviation Management, Aerospace Engineering, or a related field, along with a minimum of 5 years of experience in aviation safety, regulatory compliance, or risk management. Proven knowledge of ICAO, EASA, or FAA regulations is essential. Certifications such as Certified Aviation Safety Officer (CASO) or equivalent are highly desirable. Excellent analytical, problem-solving, and investigative skills are critical. Strong communication and presentation skills are necessary to effectively convey safety information and training across virtual platforms. This remote role offers a significant opportunity for safety professionals to make a tangible impact on aviation safety from a flexible work environment.
This advertiser has chosen not to accept applicants from your region.
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