Corporate Medical Job at Regeneron
A rare chance has emerged for aspiring professionals in the corporate medical job sector. Regeneron is seeking a Senior Manager, Pharmacovigilance Medical Review, to join their Global Patient Safety team in Hyderabad. This role offers a unique non-clinical opportunity to contribute to the development of life-changing medicines while collaborating with teams across India, the US, and the EU.
About Regeneron:
Regeneron is a leading biotechnology company that focuses on the discovery and development of innovative medicines for serious diseases. With a commitment to science and innovation, Regeneron operates globally, including in India, where it supports various medical jobs. The company is dedicated to improving patient outcomes and making a meaningful difference in the healthcare landscape.
Job Details:
- Company: Regeneron
- Position: Senior Manager, Pharmacovigilance Medical Review
- Location: Hyderabad (Hybrid)
Job Description:
In this role, the Senior Manager will lead the medical review of safety cases, ensuring that every report is scientifically sound and inspection-ready before submission to health authorities. The position involves collaboration with triage, pharmacovigilance, risk management, and clinical development partners, making it a critical role within the organization.
Key Responsibilities:
- 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.
- Mentor Managers and junior reviewers to ensure consistent application of medical and regulatory standards.
Educational Requirements for this Corporate Medical Job:
- 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.
Skills Required for this Corporate Medical Job:
- 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.
