39 Drug Safety Associate jobs in India

Drug Safety Associate

Bengaluru, Karnataka Indegene

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Title: Drug Safety Associate

Date: 22 Aug 2025 Location:

Bangalore, KA, IN

Job Description

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven. We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work.

Must Have

Associate - Pharmacovigilance Officer I You will be responsible for: "Confirm validity of case by identifying minimum criteria for case creation. � Perform duplicate search to create either an initial case or a follow-up case. � Understanding the principles and concepts associated with patient safety case-handling process including regulatory requirements for reporting individual case safety reports. � Identify serious adverse events and special scenario cases which includes lack of efficacy, exposure, and pregnancy case, at risk cases, and product quality complaint only cases. � Attach the relevant source documents or any safety information/queries/follow-up information that is relevant to the case. � Facilitate follow-up based on queries from Data entry/QC/MR or based on inconsistent/missing information in the source file. Responsible for coding which includes adverse event, medical history, Lab data, Indications etc using standardized terminology from a medical coding dictionary, such as MedDRA. � Code products (Suspect/co-suspect, Concomitant) as per Client conventions and Regulatory requirements. � Draft narratives." Your impact: About you: (Desired profile) Must have: Understand the principles and concepts associated with case-handling process and overall Drug Research Process. � Cognitive abilities including verbal reasoning, attention to detail, and critical and analytical thinking. � Good knowledge on therapy area/medical terminology. � Good comprehension skills. � Good communication (verbal and written), with fluency in English and interpersonal skills. Nice to have: (Additional desired qualities) Perks: (Mention if any, otherwise ignore) EQUAL OPPORTUNITY Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate�s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.

Good to have

EQUAL OPPORTUNITY

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.
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Junior Drug safety associate

Bengaluru, Karnataka Indegene

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Title: Junior Drug safety associate

Date: 2 Sept 2025 Location:

Bangalore, KA, IN

Job Description

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven. We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work.

Must Have

Associate - Pharmacovigilance Officer I You will be responsible for: "Confirm validity of case by identifying minimum criteria for case creation. � Perform duplicate search to create either an initial case or a follow-up case. � Understanding the principles and concepts associated with patient safety case-handling process including regulatory requirements for reporting individual case safety reports. � Identify serious adverse events and special scenario cases which includes lack of efficacy, exposure, and pregnancy case, at risk cases, and product quality complaint only cases. � Attach the relevant source documents or any safety information/queries/follow-up information that is relevant to the case. � Facilitate follow-up based on queries from Data entry/QC/MR or based on inconsistent/missing information in the source file. Responsible for coding which includes adverse event, medical history, Lab data, Indications etc using standardized terminology from a medical coding dictionary, such as MedDRA. � Code products (Suspect/co-suspect, Concomitant) as per Client conventions and Regulatory requirements. � Draft narratives." Your impact: About you: (Desired profile) Must have: Understand the principles and concepts associated with case-handling process and overall Drug Research Process. � Cognitive abilities including verbal reasoning, attention to detail, and critical and analytical thinking. � Good knowledge on therapy area/medical terminology. � Good comprehension skills. � Good communication (verbal and written), with fluency in English and interpersonal skills. Nice to have: (Additional desired qualities) Perks: (Mention if any, otherwise ignore) EQUAL OPPORTUNITY Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate�s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.

Good to have

EQUAL OPPORTUNITY

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.
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Drug Safety Associate I

Bengaluru, Karnataka Novo Nordisk

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Drug safety Associate I

Drug safety Associate I

Drug safety Associate I
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Drug Safety Admin Associate Ii

Bengaluru, Karnataka Thermo Fisher Scientific

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Coordinates the timely review of serious and non-serious adverse events; tracks all necessary data and generates reports for the client, project team and/or external vendors.
- Coordinates/facilitates project meetings, drafts meeting minutes, posts blinded and unblinded minutes/materials to client portals and distributes to internal and external project teams.
- Manages project training and the set-up archival of files; ensuring PVG remains audit ready.
- Performs data entry into internal/external database tracking systems and PPD's budget management system; performs system reconciliations to identify issues which may negatively project timelines.
- Oversees expenses and manages translations, ensuring budget parameters are not exceeded.
- Supports any specific activities performed office, which cannot be performed from elsewhere.
- Provides training to junior staff.
- In collaboration with Safety Specialist, Medical Monitors and Regulatory Publishing Specialist liaises and establishes effective relationships with internal team members to implement projects, coordinate and facilitate meetings. manage all incoming safety documentation, and accurately manage regulatory documents submissions, filing, and redactions.
- Provides support and coordination of regulatory publishing documents.
- Assists in reviewing document quality when tracking regulatory publishing data in internal systems and uploading in internal and/or external electronic trial master files.
- Ensures redactions for Commercially Confident Information and Personal Data for regulatory publishing is maintained.
- Assist in maintaining the upkeep of licenses within internal and/or external system for users across projects within IT Security standards.
- Assist with archiving of regulatory publishing documents and submissions.
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Job-Drug Safety Associate-Medical&Healthcare industry-Mumbai, Maharashtra, INDIA-upto 4 LPA-Chitra

Mumbai, Maharashtra Seven Consultancy

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JOB DETAILS


One of our clients, a reputed company in medical & healthcare industry, is seeking a Drug Safety Associate to join their growing team. In this position, you will be responsible for 
1. processing and oversight of 
a. (AE) adverse event/drug experience reports (serious and non-serious) and 
b. other safety-related data for Incite marketed products and clinical trials. 
2. case management life cycle from receipt through case completion.
FUNCTIONAL AREA
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Manager, Clinical and Safety Analytics

Hyderabad, Andhra Pradesh Bristol Myers Squibb

Posted 1 day ago

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**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:** :40:13.675 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.
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Trust & Safety Associate- Voice

Bengaluru, Karnataka Accenture

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Skill required: User-Generated Content Moderation - Content Moderation
Designation: Trust & Safety Associate
Qualifications: Any Graduation
Years of Experience: 1 to 3 years
About Accenture
Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at
What would you do? "You will be responsible for analyzing and reviewing user profiles, audio, videos, and text-based content and/or investigating, escalating and/or resolving issues that are reported by users or flagged by the system. Due to the nature of the role, the individual may be exposed to flashing lights or contrasting light and dark patterns. Content moderation is meaningful work that helps keep the internet safe. It may also be challenging, at times. In the context of this role, individuals may be directly or inadvertently exposed to potentially objectionable and sensitive content (e.g., graphic, violent, sexual, or egregious). Therefore, content moderators need strong resilience and coping skills. We care for the health and well-being of our people and provide the support and resources needed to perform their role responsibilities. Active participation in Accenture’s well-being support program, designed specifically for the Trust & Safety community, provides valuable skills to promote individual and collective well-being. "
What are we looking for? "•? 2-3 years of customer support experience via phone, email, and chat ? Experience working with direct consumers, in B2C environment; B2B is a distinct advantage ? Strong communication skills with a proactive and positive approach to tasks ? High attention to details and follow through ? An effective team player who is able to also work independently ? Proven ability to deal with problems and solve them effectively ? Professional customer service skills: solutions mindset, helping nature, passion for the customer and the customer experience ? Robust multitasking skills (e.g. able to log calls and interact with the customer simultaneously) ? Online advertising experience is a huge plus and preferred •Strong coping, emotional resilience, and stress-management skills • Excellent comprehension, communication, and English language skills • bility to perform duties objectively, devoid of inherent biases or personal beliefs, in the best interest of client policies • S rong attention to detail • C mfort synthesizing and analyzing information from multiple streams • S rong critical thinking and decision-making skills • R view, classify and/or remove content according to client guidelines, using specific tools and channels • U derstand and remain updated on changing client policies and guidelines • I vestigate, resolve, and relay complex content issues to the broader Trust and Safety team • "
Roles and Responsibilities: "•o Pro ide support to customers via live chat on various platforms. o Respond to customer inquiries in a professional and timely manner. o Assist customers in troubleshooting technical issues, placing orders, providing product information, and resolving any concerns. o Identify and resolve customer issues and complaints effectively. o Escalate unresolved issues to higher-level support teams when necessary. o Maintain a calm, positive, and helpful attitude with all customer interactions. o Stay updated with the latest product/service features, company policies, and troubleshooting steps to provide accurate information. o Provide clear and concise explanations to customers regarding products, services, or policies. o Manage multiple customer chats simultaneously while maintaining a high level of customer service. o Ensure that chat responses are efficient, clear, and accurate. o Meet performance metrics for response time, resolution time, and customer satisfaction. o Document customer interactions accurately in the system. o Log all inquiries, complaints, and solutions provided for future reference. o Maintain detailed records of customer issues and feedback for quality and training purposes. o Work closely with other team members and departments to ensure seamless service delivery. o Share feedback, best practices, and insights with the team leader to improve overall team performance. o Maintain high levels of professionalism and ensure that all interactions align with company standards and policies. o Participate in regular training sessions to improve skills and knowledge. "Any Graduation

About Accenture

We work with one shared purpose: to deliver on the promise of technology and human ingenuity. Every day, more than 775,000 of us help our stakeholders continuously reinvent. Together, we drive positive change and deliver value to our clients, partners, shareholders, communities, and each other.We believe that delivering value requires innovation, and innovation thrives in an inclusive and diverse environment. We actively foster a workplace free from bias, where everyone feels a sense of belonging and is respected and empowered to do their best work.At Accenture, we see well-being holistically, supporting our people’s physical, mental, and financial health. We also provide opportunities to keep skills relevant through certifications, learning, and diverse work experiences. We’re proud to be consistently recognized as one of the World’s Best Workplaces™.Join Accenture to work at the heart of change.

Visit us at

Equal Employment Opportunity Statement


We believe that no one should be discriminated against because of their differences. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, militaryveteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by applicablelaw. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities.

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Trust & Safety Associate- Voice

Koramangala, Karnataka Accenture

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Job Description

Skill required: User-Generated Content Moderation - Content Moderation
Designation: Trust & Safety Associate
Qualifications: Any Graduation
Years of Experience: 1 to 3 years
About Accenture
Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at
What would you do? "You will be responsible for analyzing and reviewing user profiles, audio, videos, and text-based content and/or investigating, escalating and/or resolving issues that are reported by users or flagged by the system. Due to the nature of the role, the individual may be exposed to flashing lights or contrasting light and dark patterns. Content moderation is meaningful work that helps keep the internet safe. It may also be challenging, at times. In the context of this role, individuals may be directly or inadvertently exposed to potentially objectionable and sensitive content (e.g., graphic, violent, sexual, or egregious). Therefore, content moderators need strong resilience and coping skills. We care for the health and well-being of our people and provide the support and resources needed to perform their role responsibilities. Active participation in Accenture’s well-being support program, designed specifically for the Trust & Safety community, provides valuable skills to promote individual and collective well-being. "
What are we looking for? "•? 2-3 years of customer support experience via phone, email, and chat ? Experience working with direct consumers, in B2C environment; B2B is a distinct advantage ? Strong communication skills with a proactive and positive approach to tasks ? High attention to details and follow through ? An effective team player who is able to also work independently ? Proven ability to deal with problems and solve them effectively ? Professional customer service skills: solutions mindset, helping nature, passion for the customer and the customer experience ? Robust multitasking skills (e.g. able to log calls and interact with the customer simultaneously) ? Online advertising experience is a huge plus and preferred •Strong coping, emotional resilience, and stress-management skills • Excellent comprehension, communication, and English language skills • bility to perform duties objectively, devoid of inherent biases or personal beliefs, in the best interest of client policies • S rong attention to detail • C mfort synthesizing and analyzing information from multiple streams • S rong critical thinking and decision-making skills • R view, classify and/or remove content according to client guidelines, using specific tools and channels • U derstand and remain updated on changing client policies and guidelines • I vestigate, resolve, and relay complex content issues to the broader Trust and Safety team • "
Roles and Responsibilities: "•o Pro ide support to customers via live chat on various platforms. o Respond to customer inquiries in a professional and timely manner. o Assist customers in troubleshooting technical issues, placing orders, providing product information, and resolving any concerns. o Identify and resolve customer issues and complaints effectively. o Escalate unresolved issues to higher-level support teams when necessary. o Maintain a calm, positive, and helpful attitude with all customer interactions. o Stay updated with the latest product/service features, company policies, and troubleshooting steps to provide accurate information. o Provide clear and concise explanations to customers regarding products, services, or policies. o Manage multiple customer chats simultaneously while maintaining a high level of customer service. o Ensure that chat responses are efficient, clear, and accurate. o Meet performance metrics for response time, resolution time, and customer satisfaction. o Document customer interactions accurately in the system. o Log all inquiries, complaints, and solutions provided for future reference. o Maintain detailed records of customer issues and feedback for quality and training purposes. o Work closely with other team members and departments to ensure seamless service delivery. o Share feedback, best practices, and insights with the team leader to improve overall team performance. o Maintain high levels of professionalism and ensure that all interactions align with company standards and policies. o Participate in regular training sessions to improve skills and knowledge. "Any Graduation

About Accenture

We work with one shared purpose: to deliver on the promise of technology and human ingenuity. Every day, more than 775,000 of us help our stakeholders continuously reinvent. Together, we drive positive change and deliver value to our clients, partners, shareholders, communities, and each other.We believe that delivering value requires innovation, and innovation thrives in an inclusive and diverse environment. We actively foster a workplace free from bias, where everyone feels a sense of belonging and is respected and empowered to do their best work.At Accenture, we see well-being holistically, supporting our people’s physical, mental, and financial health. We also provide opportunities to keep skills relevant through certifications, learning, and diverse work experiences. We’re proud to be consistently recognized as one of the World’s Best Workplaces™.Join Accenture to work at the heart of change.

Visit us at

Equal Employment Opportunity Statement


We believe that no one should be discriminated against because of their differences. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, militaryveteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by applicablelaw. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities.

This advertiser has chosen not to accept applicants from your region.

Drug Safety Physician

Chennai, Tamil Nadu ICON Clinical Research

Posted 3 days ago

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Drug Safety Physician
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Drug Safety Physician to join our diverse and dynamic team. As a Drug Safety Physician at ICON, you will play a pivotal role in overseeing the medical aspects of pharmacovigilance activities, ensuring the safety of investigational drugs and contributing to the advancement of inNvative treatments and therapies.
**What you will be doing**
+ Review of coding (e.g. MedDRA) and accurate assessment (seriousness, expectedness, listedness, relatedness) of Adverse Events (serious and non-serious) and of Adverse Drug Reactions (serious and non-serious)
+ Provide support to the Drug Information & Pharmacovigilance Product Support (call) Centre and
+ the related projects, including provision of the Product related information to the callers as well as review and assessment of reported adverse reactions
+ Review of aggregated reports (e.g. patient profiles, line listings, IND annual reports, Annual Safety Reports, Periodic Safety Update Reports) in terms of Product safety profile
+ Provide assessment of safety issues arising in clinical trials or in the post-marketing setting and escalate those to the line manager within ICON and discuss the agreed approach on resolution with the client
+ Provide support/training in all aspects of regulatory requirements for expedited and periodic reporting of AEs/ADRs originating from clinical trials, post authorisation studies, spontaneous reporting and literature
+ Review and provide input to the Project Specific Procedures and participate in project related meetings
+ Communicate with the client to an extent as described in the Project Specific Procedures
+ Provide assistance in the preparation and conduct of code-break activities
+ Review, asses and provide input to Clinical Trial Protocols, Product Information, Company Core
+ Data Sheet and any other product related information as required by the client in the course of assigned project
+ Provide input and consultancy to the client in the course of generation of the Company Core
+ Data Sheet/Core Safety Information and Product Information
+ Provide pharmacovigilance consultancy to the client in terms of regulatory requirements for expedited and periodic reporting of AEs/ADRs originating from clinical trials, post-authorisation studies, spontaneous reporting and literature
+ Provide guidance to Medical and Safety Services staff with regards to the regulatory reporting of adverse event
+ Other responsibilities as assigned.
**Your profile**
+ Medical degree (MD or equivalent) with active medical license.
+ Board certification or equivalent experience in a relevant medical specialty (e.g., internal medicine, pharmacology).
+ Previous experience in pharmacovigilance or drug safety within the pharmaceutical or biotechNlogy industry preferred.
+ Strong clinical judgment and analytical skills, with the ability to interpret complex medical data and make informed decisions.
+ Excellent communication and collaboration skills, with the ability to work effectively within a multidisciplinary team environment.
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here ( to apply
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