Regeneron Hiring Manager Medical Review in Hyderabad, India

The Regeneron Manager Medical Review opening is now live: Regeneron is hiring a Manager, Medical Review for its Global Patient Safety POD in Hyderabad, India. This is a full-time, hybrid role in the Global Development team.

Job Details

  • Company: Regeneron
  • Job Title: Manager Medical Review
  • Team: Global Development
  • Location: Hyderabad, India
  • Req ID: R47718
  • Contract: Full time
  • Work Pattern: Hybrid

Regeneron Manager Medical Review Job Description

At Regeneron, Global Patient Safety helps protect patients by ensuring safety information is evaluated with scientific rigor and documented to the highest quality standards. As Manager, Medical Review, you will join our India-based Global Patient Safety POD and lead the end-to-end medical review of Individual Case Safety Reports from global development programs and selected marketed products. Your clinical judgement will shape accurate coding, expectedness and causality decisions, clear case narratives, and inspection-ready submissions. Working closely with triage colleagues and US- and EU-based safety partners, you will help create cohesive case documentation, strengthen pharmacovigilance processes, and explore responsible uses of new technologies, including AI.

Key Responsibilities

  • Perform complete medical review of Individual Case Safety Reports within defined timelines, ensuring clinically important information is accurately captured.
  • Review and strengthen case narratives, analyses of similar events, company causality rationales, and reporting decisions.
  • Determine expectedness using current reference safety information, including investigator brochures, US prescribing information, and summaries of product characteristics.
  • Apply clinically appropriate MedDRA coding to adverse events and medical histories in line with Global Patient Safety standards.
  • Partner with pharmacovigilance teams, risk management leads, and clinical development leads to produce cohesive, submission-ready case documentation.
  • Serve as a medical resource for assigned Regeneron compounds, resolve case-level questions, and escalate complex issues when needed.
  • Contribute to standard operating procedures, process improvements, and inspection-readiness activities across Global Patient Safety.
  • Explore innovative ways to improve core activities through new technologies, including AI and generative AI.

Eligibility Criteria

  • An MD or MBBS, with active registration or eligibility for registration with the relevant Indian professional regulatory body.
  • 7-9 years of pharmacovigilance experience, including hands-on medical review of Individual Case Safety Reports, is expected for the Regeneron Manager Medical Review position.

Required Skills

  • Demonstrated experience in narrative authoring, MedDRA coding, causality assessment, and expectedness determination.
  • Strong knowledge of ICH E2A, E2B, and E2D guidelines, along with FDA and EMA pharmacovigilance requirements for case processing and expedited reporting.
  • Proficiency with Oracle Argus Safety or an equivalent safety database, supported by sound clinical judgement and clear written reasoning.
  • The ability to work independently while collaborating effectively with global, cross-functional partners.
  • Experience supporting global development programs or marketed products.
  • Experience in a Global Patient Safety POD, insourced pharmacovigilance model, or similar integrated operating structure.
  • Exposure to AI or generative AI tools in pharmacovigilance, safety review, or clinical documentation.

How to Apply for Regeneron Manager Medical Review

Apply now to take your first step towards living the Regeneron Way! Apply through the Regeneron Workday portal

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Apply for the Regeneron Manager Medical Review role through the Regeneron careers portal or the Workday link above.