14 Pharmacovigilance Assistant I jobs in India

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

This job is curated by Lifelancer.

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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 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. If this excites you, then apply below:

Job Title: Medical Reviewer – Pharmacovigilance

Location:

Work from office: Bangalore, Hyderabad, Mumbai, Pune, Delhi

Willingness to relocate to one of the above locations is mandatory.

Education Requirements:

• MBBS and MD (mandatory)
• Candidates without both qualifications will not be considered.

Job Title: Medical Reviewer – Pharmacovigilance

Location:

Work from office: Bangalore, Hyderabad, Mumbai, Pune, Delhi

Willingness to relocate to one of the above locations is mandatory.

Education Requirements:

• MBBS, MD(mandatory)
• Medical council of India registration ( Mandatory)

Job Description:

As a Medical Reviewer – Pharmacovigilance , you will be responsible for the comprehensive medical review of individual case safety reports (ICSRs) and ensuring compliance with regulatory and client-specific requirements. You will play a critical role in safeguarding patient safety through high-quality medical evaluation and regulatory reporting.

Key Responsibilities:

• Perform medical review of ICSRs for accuracy , medical relevance , and consistency with the source documents and safety database entries, in alignment with client requirements.
• Conduct second-level triaging of non-serious cases to identify any potential serious adverse events (SAEs), as per client-specific conventions.
• Review and validate:
• Suspect product coding
• Event selection and MedDRA coding (current version)
• Grouping/subsuming and event ordering
• Confirm and correct:
• Event coding and classification
• Ranking of events, seriousness criteria, and listedness/expectedness
• Perform comprehensive medical evaluation of adverse event reports including serious/expedited cases and pregnancy-related reports.
• Assess adverse events for seriousness , listedness , and causality , ensuring all medically relevant data from source documents is accurately reflected.
• Review and enhance narratives in compliance with client conventions.
• Provide or verify company pharmacovigilance (PV) comments as needed.
• Initiate appropriate follow-up queries based on the clinical context of the case.
• Identify and escalate potential safety signals or concerns in line with client procedures.
• Ensure completeness and medical soundness of cases before providing final medical sign-off .
• Assess malfunctions and serious injury/death outcomes in relation to combination products.
• Participate in literature surveillance and aggregate report medical review, ensuring compliance with regulatory timelines and SOPs.
• Track and document inconsistencies in data entry and provide feedback for continuous improvement.
• Collaborate closely with cross-functional teams to maintain scientific accuracy , clarity , and regulatory compliance in all case documentation.
• Stay updated with international pharmacovigilance regulations and follow all applicable SOPs , guidelines , and best practices .
• Attend mandatory internal and client-specific trainings to ensure continuous compliance.

Required Skills and Competencies:

• Strong analytical and critical thinking abilities
• High attention to detail and scientific accuracy
• Sound medical judgment and decision-making in line with pharmacovigilance standards
• Proficiency in medical terminology , disease pathology, pharmacology, and therapeutics
• Ability to analyze and interpret adverse event data
• Strong written and verbal communication skills
• Good comprehension and the ability to summarize complex medical data
• Team player with effective interpersonal and collaboration skills
• Familiarity with pharmaceutical industry practices and drug development processes (preferred)

Additional Requirements:

• Willing to relocate to any of the listed office locations.
• Ready to work from the office with hybrid options
• Must possess MBBS and MD degrees (non-negotiable)

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.

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 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. If this excites you, then apply below:

Job Title: Medical Reviewer – Pharmacovigilance

Location:

Work from office: Bangalore, Hyderabad, Mumbai, Pune, Delhi

Willingness to relocate to one of the above locations is mandatory.

Education Requirements:

• MBBS and MD (mandatory)
• Candidates without both qualifications will not be considered.

Job Title: Medical Reviewer – Pharmacovigilance

Location:

Work from office: Bangalore, Hyderabad, Mumbai, Pune, Delhi

Willingness to relocate to one of the above locations is mandatory.

Education Requirements:

• MBBS, MD(mandatory)
• Medical council of India registration ( Mandatory)

Job Description:

As a Medical Reviewer – Pharmacovigilance, you will be responsible for the comprehensive medical review of individual case safety reports (ICSRs) and ensuring compliance with regulatory and client-specific requirements. You will play a critical role in safeguarding patient safety through high-quality medical evaluation and regulatory reporting.

Key Responsibilities:

• Perform medical review of ICSRs for accuracy, medical relevance, and consistency with the source documents and safety database entries, in alignment with client requirements.
• Conduct second-level triaging of non-serious cases to identify any potential serious adverse events (SAEs), as per client-specific conventions.
• Review and validate:
• Suspect product coding
• Event selection and MedDRA coding (current version)
• Grouping/subsuming and event ordering
• Confirm and correct:
• Event coding and classification
• Ranking of events, seriousness criteria, and listedness/expectedness
• Perform comprehensive medical evaluation of adverse event reports including serious/expedited cases and pregnancy-related reports.
• Assess adverse events for seriousness, listedness, and causality, ensuring all medically relevant data from source documents is accurately reflected.
• Review and enhance narratives in compliance with client conventions.
• Provide or verify company pharmacovigilance (PV) comments as needed.
• Initiate appropriate follow-up queries based on the clinical context of the case.
• Identify and escalate potential safety signals or concerns in line with client procedures.
• Ensure completeness and medical soundness of cases before providing final medical sign-off.
• Assess malfunctions and serious injury/death outcomes in relation to combination products.
• Participate in literature surveillance and aggregate report medical review, ensuring compliance with regulatory timelines and SOPs.
• Track and document inconsistencies in data entry and provide feedback for continuous improvement.
• Collaborate closely with cross-functional teams to maintain scientific accuracy, clarity, and regulatory compliance in all case documentation.
• Stay updated with international pharmacovigilance regulations and follow all applicable SOPs, guidelines, and best practices.
• Attend mandatory internal and client-specific trainings to ensure continuous compliance.

Required Skills and Competencies:

• Strong analytical and critical thinking abilities
• High attention to detail and scientific accuracy
• Sound medical judgment and decision-making in line with pharmacovigilance standards
• Proficiency in medical terminology, disease pathology, pharmacology, and therapeutics
• Ability to analyze and interpret adverse event data
• Strong written and verbal communication skills
• Good comprehension and the ability to summarize complex medical data
• Team player with effective interpersonal and collaboration skills
• Familiarity with pharmaceutical industry practices and drug development processes (preferred)

Additional Requirements:

• Willing to relocate to any of the listed office locations.
• Ready to work from the office with hybrid options
• Must possess MBBS and MD degrees (non-negotiable)

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.