Associate Director, Triage and Medical Review

About Regeneron

Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health.

As the Associate Director, Triage and Medical Review Team Lead, you will oversee the complete triage and medical review of Individual Case Safety Reports (ICSRs) from global development programs and selected globally marketed products within the India-based Global Patient Safety (GPS) POD. This role is responsible for ensuring end-to-end case quality, inspection readiness, and alignment with global pharmacovigilance standards while partnering closely with global GPS teams.

This position is office-based and will be on site at Regeneron’s Hyderabad office.

A Typical Day May Include:

• Overseeing the complete medical review of ICSRs, ensuring all medically relevant information is accurately captured in Argus

• Leading and overseeing the triage team to ensure harmonization of triage and medical review activities

• Developing innovative approaches to enhance core activities through integration of new technologies, including AI

• Reviewing and updating case narratives, author analyses, company causality rationale, and ensuring documentation is clinically accurate and aligned with reporting decisions

• Providing guidance and oversight on expectedness determinations in alignment with development programs, marketed products, and approved labeling documents

• Overseeing MedDRA coding of adverse events and medical history to ensure clinical appropriateness and consistency with GPS standards

• Collaborating across PV teams, RM leads, and clinical development teams to produce comprehensive case documentation prior to regulatory submissions

• Serving as the medical resource for assigned Regeneron compounds within the GPS POD and resolving case-level issues as needed

• Supporting SOP development, process improvements, and inspection readiness activities within GPS

This Role May Be for You If You Have:

• Exceptional knowledge of ICH E2A, E2B, and E2D guidelines along with FDA/EMA pharmacovigilance regulations governing ICSR processing and expedited reporting

• Strong expertise in independent medical review of ICSRs, including narrative authoring, causality assessment, and expectedness determination

• Strong proficiency with Argus Safety or equivalent safety databases

• Advanced MedDRA coding proficiency with consistent clinically appropriate term selection

• Strong clinical judgment and the ability to assess complex cases and communicate rationale clearly in written documentation

• Experience or interest in AI technologies within pharmacovigilance operations

To Be Considered for This Role:

• 10+ years of total industry experience, including a minimum of 7+ years of pharmacovigilance experience.

• You must have an MD/MBBS degree with active registration or eligibility for registration with the relevant Indian professional regulatory body.

• Hands-on experience in ICSR medical review, including narrative authoring, MedDRA coding, causality assessment, and expectedness determination

• Experience supporting global development programs or marketed products preferred

• Prior experience in a GPS POD or insourced PV model is an added advantage