Medical Reviewer-Drug Safety Physician

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 enable healthcare organizations be future ready and our customer obsession is our driving force. Job Title: Medical Reviewer – Pharmacovigilance
Work from office: Willingness to relocate to one of the above locations is mandatory.
MBBS and MD (mandatory)
Job Title: Medical Reviewer – Pharmacovigilance
Work from office: Willingness to relocate to one of the above locations is mandatory.

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

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.
Perform medical review of ICSRs for accuracy , medical relevance , and consistency with the source documents and safety database entries, in alignment with client requirements.
Suspect product coding
Event selection and MedDRA coding (current version)
Event coding and classification
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.
Provide or verify company pharmacovigilance (PV) comments as needed.
Initiate appropriate follow-up queries based on the clinical context of the case.
Ensure completeness and medical soundness of cases before providing final medical sign-off .
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 .
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
Good comprehension and the ability to summarize complex medical data
Familiarity with pharmaceutical industry practices and drug development processes (preferred)

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)

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. 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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