Senior Manager, Kite Safety and Pharmacovigilance

Role: Senior Manager, Kite Safety and Pharmacovigilance, providing scientific and strategic leadership for safety monitoring of Kite’s investigational and marketed cancer therapies, including CAR T-cell products. Responsibilities: lead complex safety analyses, author aggregate safety reports (e.g., PSURs, PBRERs, DSURs), support regulatory submissions, manage safety signal detection, and liaise with health authorities on safety issues. Ensure compliance with global pharmacovigilance regulations, develop safety content for clinical and post-marketing documents, and serve as safety lead in cross-functional teams. Requirements: MD with minimal experience or advanced degrees with 2+ years (Doctorate), or 6+ years (Master’s), or 8+ years (Bachelor’s) in pharmacovigilance or related fields. Preferred skills include 5+ years of direct PV experience, knowledge of FDA, EMA, ICH regulations, and safety databases such as Argus, Rave, MedDRA. Strong scientific writing and cross-functional collaboration skills are essential. High-Value: focus on oncology, immunotherapy, CAR T-cell therapies, late-stage development (clinical to post-marketing), cross-functional safety strategy, regulatory interactions, and GVP compliance. WorkSetup: Based in Santa Monica, CA, with a focus on remote/hybrid options, specific travel requirements not specified.