Job Description
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
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.