Regeneron Hiring Medical Review Senior Manager

Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® (RGC) and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.

Post : Senior Manager Medical Review

Job Description
• Act as team lead, owning end-to-end case quality from coding through causality to final company comment
• Perform and oversee medical review of ICSRs within defined time standards, ensuring accuracy in Argus
• Author and review case narratives, analysis of similar events, and company causality rationale
• Code adverse events and medical history using MedDRA in line with global safety standards
• Partner with triage, PV, risk management, and clinical development teams on inspection-ready documentation
• Serve as the medical resource for assigned compounds, resolving and escalating complex case issues
• Drive SOP development, process improvement, and integration of new technologies including AI
• You mentor Managers and junior reviewers to ensure consistent application of medical and regulatory standards

Candidate Profile
• MD or MBBS with active registration, or eligibility for registration, with the relevant Indian professional regulatory body
• Minimum 8–10 years of pharmacovigilance experience with hands-on ICSR medical review, including narrative authoring, causality assessment, and expectedness determination
• Strong knowledge of ICH E2A, E2B, and E2D guidelines and FDA/EMA pharmacovigilance regulations
• Proficiency with Argus Safety or an equivalent safety database and MedDRA coding
• Sound clinical judgment with the ability to assess complex cases and communicate reasoning clearly in writing
• Experience within global development programs or on marketed products preferred
• Exposure to AI or generative AI tools in pharmacovigilance or clinical documentation a plus

Additional Information
Experience : 8–10 years
Qualification : MD or MBBS with active registration, or eligibility for registration
Location : Hyderabad, Telangana
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Global Development
End Date : 30th October 2026