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Senior Manager, Kite Safety and Pharmacovigilance
Job in
California, Moniteau County, Missouri, 65018, USA
Listed on 2026-10-06
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-10-06
Job specializations:
-
Healthcare
Healthcare Compliance, Clinical Research
Job Description & How to Apply Below
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.
- 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.
- Strong scientific writing and cross-functional collaboration skills are essential.
- 5+ years of direct PV experience, knowledge of FDA, EMA, ICH regulations, and safety databases such as Argus, Rave, MedDRA.
focus on oncology, immunotherapy, CAR T-cell therapies, late-stage development (clinical to post-marketing), cross-functional safety strategy, regulatory interactions, and GVP compliance.
Work SetupBased in Santa Monica, CA, with a focus on remote/hybrid options, specific travel requirements not specified.
Position Requirements
10+ Years
work experience
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