Senior Manager, Kite Safety and Pharmacovigilance
Core
Provide scientific and strategic leadership for pharmacovigilance activities supporting investigational and marketed CAR T-cell cancer therapies.
Role type
Senior Manager, Pharmacovigilance Science Lead
Builds
Aggregate safety reports (PSURs, PBRERs, DSURs), regulatory submissions, product labeling, and safety strategy execution for Kite's cell therapies.
Domain
Biopharmaceuticals / Oncology / Cell Therapy
Required skills
Medical writing, safety signal detection, regulatory compliance (FDA/EMA/ICH), cross-functional leadership, audit/inspection readiness, scientific judgment
Preferred skills
Aggregate reporting expertise, safety database management, matrixed team leadership, diverse team inclusion
Technologies
Argus, Rave, MedDRA, WHO Drug
Responsibilities
Lead authoring of complex aggregate safety reports; design search strategies and evaluate safety data; prepare responses to global health authorities; support product labeling development; partner with Clinical and Regulatory teams on safety content; ensure compliance with global regulations.
Seniority
Senior Manager, hands-on IC with people leadership
