Associate Director, Pharmacovigilance/ Product Safety

Role: Associate Director, Pharmacovigilance/Product Safety, responsible for medical safety assessment of Insmed’s products throughout their lifecycle, including post-marketing. Responsibilities: evaluate AE/SAE reports, prepare safety analyses, contribute to risk management plans, author safety-related regulatory submissions, and review emerging safety data from clinical and non-clinical sources. Collaborate with vendors and internal safety committees. Requirements: Master’s, RN, PharmD, or MD; 3-5 years in pharmacovigilance or safety leadership in pharma; experience with clinical and post-marketing safety data; strong knowledge of pharmacovigilance regulations, MedDRA, safety databases; excellent communication and organizational skills. Preferred: device experience. HighValue: biologics or small molecules, post-marketing safety, global regulatory environment, remote work with occasional travel (~10%). Reporting: to Executive Director, DSPV Medical Safety. Work setup: fully remote, minimal travel.