Senior Manager, Kite Safety and Pharmacovigilance

Role: Senior Manager, Kite Safety and Pharmacovigilance, providing scientific leadership for safety monitoring of Kite's investigational and marketed cancer therapies. Responsibilities: lead safety data analyses, author complex safety reports (PSURs, PBRERs, DSURs), support regulatory submissions, manage safety signals, and engage with health authorities on safety issues. Oversee compliance with global pharmacovigilance regulations, serve as safety lead across functions, and contribute to safety content for clinical and post-marketing documents. Requirements: MD (0+ years), Doctorate (2+ years), Master’s (6+ years), or Bachelor’s (8+ years) with relevant pharmacovigilance experience. Preferred: 5+ years in pharmacovigilance, strong knowledge of FDA, EMA, ICH regulations, experience with safety databases (Argus, Rave), and medical writing skills. HighValue: focus on cancer immunotherapies, CAR T-cell products, regulatory safety reporting, GxP compliance, cross-functional collaboration with Clinical, Regulatory, Medical Affairs. WorkSetup: not specified, includes regulatory and safety strategy execution.