Associate Director, Pharmacovigilance/Product Safety
About the role
At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? We’re looking for an Associate Director, Pharmacovigilance/ Product Safety on the Drug Safety & Pharmacovigilance team to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, DSPV Medical Safety, you’ll provide medical expertise regarding the safety and risk assessment of Insmed products at all stages of the product life cycle (clinical to post‑marketing). This individual will ensure that the safety data are evaluated medically and put in context thus underpinning risk management initiatives. This individual will have responsibility for medical assessment and medical review activities and may contribute to safety sections of safety and non‑safety documents.
Responsibilities
- Provide medical significance and expectedness assessment of AE/SAE reports and approving AE/SAE case narratives prepared by vendors or Insmed.
- Compile analysis of similar events (AOSE), individual case comments, RMP analyses, and ad-hoc safety analyses as required by health authorities or corporate policy.
- Provide medical input for maintaining RMP and post-marketing safety monitoring commitments
- Provide periodic benefit-risk assessment reports for internal use
- Invest