Director, Drug Safety & Pharmacovigilance

Role: Director, Drug Safety & Pharmacovigilance responsible for overseeing all safety monitoring activities for biopharma products, including signal detection, safety data review, and regulatory reporting. Responsibilities: manage safety processes for assigned assets, collaborate with cross-functional teams on safety reviews, contribute to safety documentation (e.g., DSURs, aggregate reports), and ensure compliance with global PV regulations and standards. Serve as subject matter expert on pharmacovigilance activities, oversee vendor relationships, and participate in inspection readiness. Requirements: advanced nursing degree or PharmD; minimum 8 years of drug safety experience; extensive experience in case review, signal detection, and safety data analysis; strong knowledge of international PV regulations, safety databases (e.g., Argus), and MedDRA coding. Preferred: MD, experience in oncology or autoimmune drug development, and clinical background in critical care. High-Value: biopharma, clinical-stage, focus on cancer and serious diseases, safety reporting, and regulatory compliance. Collaboration: work closely with medical, clinical, and regulatory teams; may involve managing direct/indirect reports. Work Setup: hybrid in San Diego or fully remote if not local; occasional travel between Pasadena and San Diego.