271 Drug Safety Associates jobs in India
Drug Safety Associate
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Title: Drug Safety Associate
Date: 22 Aug 2025 Location:Pune, MH, 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.Drug Safety Physician
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Job Title: Drug Safety Physician
Job Location: Chennai, Tamil Nadu, India
Job Location Type: On-site
Job Contract Type: Permanent
Job Seniority Level:
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
Interested 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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Drug Safety Associate
Posted today
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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.Drug Safety Associate
Posted today
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Job Description
- Reviewing adverse event reports, safety data sheets, and physician advisories to identify potential risks associated with a particular drug
- Conducting site visits to observe the distribution process to ensure compliance with federal regulations
- Monitoring compliance with drug licensing laws and regulations
- Ensuring the safe handling of pharmaceuticals by maintaining proper storage conditions
- Preparing reports about the status of drug inventories and other pertinent information to management
- Suggesting methods to improve workflow processes within the pharmacy department
- Administering medications to individuals according to established protocols
- Providing assistance in the investigation of medication errors or problems with drug labeling or packaging
**Salary**: ₹28,000.00 - ₹54,000.00 per month
**Benefits**:
- Cell phone reimbursement
- Work from home
Schedule:
- Day shift
Supplemental pay types:
- Overtime pay
- Performance bonus
Drug Safety Associate
Posted today
Job Viewed
Job Description
- Reviewing adverse event reports, safety data sheets, and physician advisories to identify potential risks associated with a particular drug
- Conducting site visits to observe the distribution process to ensure compliance with federal regulations
- Monitoring compliance with drug licensing laws and regulations
- Ensuring the safe handling of pharmaceuticals by maintaining proper storage conditions
- Preparing reports about the status of drug inventories and other pertinent information to management
- Suggesting methods to improve workflow processes within the pharmacy department
- Administering medications to individuals according to established protocols
- Providing assistance in the investigation of medication errors or problems with drug labeling or packaging
**Salary**: ₹19,000.00 - ₹39,000.00 per month
**Benefits**:
- Cell phone reimbursement
- Flexible schedule
- Work from home
Schedule:
- Day shift
Supplemental pay types:
- Performance bonus
Drug Safety Associate
Posted today
Job Viewed
Job Description
Drug safety associates have a wide range of responsibilities, which can include:
- Reviewing adverse event reports, safety data sheets, and physician advisories to identify potential risks associated with a particular drug
- Conducting site visits to observe the distribution process to ensure compliance with federal regulations
- Monitoring compliance with drug licensing laws and regulations
- Ensuring the safe handling of pharmaceuticals by maintaining proper storage conditions
- Preparing reports about the status of drug inventories and other pertinent information to management
- Suggesting methods to improve workflow processes within the pharmacy department
- Administering medications to individuals according to established protocols
- Providing assistance in the investigation of medication errors or problems with drug labeling or packaging
Pay: ₹8,086.00 - ₹41,022.41 per month
**Benefits**:
- Internet reimbursement
Schedule:
- Day shift
Supplemental pay types:
- Performance bonus
Ability to commute/relocate:
- Lucknow, Uttar Pradesh: Reliably commute or planning to relocate before starting work (required)
**Experience**:
- total work: 1 year (preferred)
Drug Safety Associate
Posted today
Job Viewed
Job Description
Drug safety associates responsibilities include:
- Reviewing adverse event reports, safety data sheets, and physician advisories to identify potential risks associated with a particular drug
- Conducting site visits to observe the distribution process to ensure compliance with federal regulations
- Monitoring compliance with drug licensing laws and regulations
- Ensuring the safe handling of pharmaceuticals by maintaining proper storage conditions
- Preparing reports about the status of drug inventories and other pertinent information to management
- Suggesting methods to improve workflow processes within the pharmacy department
- Administering medications to individuals according to established protocols
- Providing assistance in the investigation of medication errors or problems with drug labeling or packaging
**Salary**: ₹14,940.66 - ₹34,094.01 per month
**Benefits**:
- Internet reimbursement
Schedule:
- Day shift
Supplemental pay types:
- Performance bonus
Ability to commute/relocate:
- Bangalore, Karnataka: Reliably commute or planning to relocate before starting work (required)
**Experience**:
- total work: 1 year (preferred)
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Drug Safety Physician
Posted today
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- Provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products
- Signal detection/analysis/evaluation and ongoing safety surveillance activities
- Provide medical guidance and input to Drug Safety associates (DSAs) and specialists in medical aspects of drug safety
- Provide medical advice/input for narratives written for Clinical Study Reports (CSRs)
- Provide medical, safety input and review of all required safety reports, Benefit Risk Assessment, Safety Evaluation Reports (SERs), Clinical Overview (COs), clinical Expert Statement, Investigator notification letters
- Function as pharmacovigilance representative/safety scientist
**General**:
- Maintaining a good working knowledge of the Adverse event profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and international drug safety regulations
- Maintaining an awareness of global regulatory requirements and reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
- Maintaining excellent knowledge of the safety profile of assigned products
- Communicating and discussing issues related to review process with Project Manager
- Interacting with internal and external contacts for resolving issues
- Maintaining a good working knowledge of relevant regulatory guidelines
- Attend and present client/cross functional meetings along with other stakeholders
**Case report Medical review**
- Performing medical review of cases according to client Standard Operating Procedures (SOPs) and liaising with the client, as required
- Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality
- Assessing seriousness and expectedness of reported events
- Providing medical advice to case processing team
**Literature review**
- Review of literature for product safety assessment and potential safety issues
**Skills**:
- Excellent interpersonal, verbal and written communication skills
- Review of literature for product safety assessment and potential safety issues
- Client focused approach to work
- A flexible attitude with respect to work assignments and new learnings
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
- Ability to assess the clinical relevance of medical data and to interpret its clinical meaning is essential
- Willingness to work in a matrix environment and to value the importance of teamwork
- Strong knowledge of international drug regulation including GCP, GVP
**Knowledge and Experience**:
Good knowledge of medical terminology.
Fresher/ relevant experience into pharmacovigilance/ Drug Safety field is preferred.
**Education**:
Graduation/Post Graduation in Medicine.
Junior Drug safety associate
Posted today
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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.