Director, Safety & Pharmacovigilance (PV)

Role: The Director of Pharmacovigilance & Patient Safety provides medical and operational leadership for safety activities in Ocugen’s ocular gene therapy clinical portfolio, focusing on safety surveillance, case assessment, signal detection, benefit–risk evaluation, and vendor oversight. Responsibilities include acting as safety physician, reviewing and approving serious adverse events, evaluating safety data for signals, contributing to regulatory documents, developing safety strategies specific to gene therapy (ocular inflammation, immunogenicity, vector shedding), managing PV activities, leading safety review activities, and supporting audits and inspections. Requirements: MD or DO strongly preferred, with 7+ years in biotech/pharma PV, including hands-on safety physician experience; expertise in case assessment, aggregate data analysis, and regulatory document review; knowledge of FDA, EMA, ICH guidelines, MedDRA, and PV systems. Preferred qualifications include gene/cell therapy experience, ophthalmology/retinal disease background, experience with pivotal programs, BLA/MAA prep, and safety databases like Argus or ArisGlobal. The role necessitates strong judgment, communication, and organizational skills, with an emphasis on independent execution of critical safety work. The position is based in an office setting with potential outside hours; travel is not specified.