Associate Director, Triage and Medical Review

Regeneron; Hyderabad; Sur place; INR 11 450 382 - 15 267 176; Plein temps

Avantages offerts par ce poste

Annual bonuses

Health and wellness programs

Paid time off

Résumé du poste

Regeneron is seeking an Associate Director for the Triage and Medical Review Team in Hyderabad. This role oversees the medical review of Individual Case Safety Reports, ensuring compliance with pharmacovigilance standards.

The ideal candidate will have substantial experience in pharmacovigilance and a strong clinical background. Responsibilities include supervising the triage team, enhancing processes, and collaborating across teams to produce comprehensive case documentation.

Regeneron offers a competitive total rewards package and values diversity in its workforce.

Qualifications

• 10+ years of total industry experience.
• Minimum of 7+ years of pharmacovigilance experience.
• Hands-on experience in ICSR medical review.

Responsabilités

• Oversee medical review of ICSR.
• Lead the triage team for harmonization.
• Develop innovative approaches with AI.

Connaissances

Knowledge of ICH E2A, E2B, E2D guidelines

Independent medical review of ICSR

Proficiency with Argus Safety

MedDRA coding proficiency

Clinical judgment

Experience in AI technologies

Formation

MD/MBBS degree with registration eligibility

Outils

Argus Safety

Description du poste

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 IC SRs, 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 IC SRs, 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

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.