Manager, Pharmacovigilance Operations

Role: Manager, Pharmacovigilance Operations supporting drug safety for allogeneic CAR T cell therapies in clinical development and post-marketing. Responsibilities: oversee safety vendor activities, manage adverse event reporting and regulatory submissions (DSURs, ICSR), facilitate safety documentation updates, support audits and inspections, and ensure compliance with global PV regulations. Collaboration with cross-functional teams and external vendors is key. Requirements: Bachelor's in life sciences or healthcare, 5+ years of pharmacovigilance experience in biotech/pharma, strong knowledge of US and ex-US PV regulations, proficiency in safety systems (Oracle Argus, ARISg, MedDRA, WHODrug, SPEED), excellent organizational and communication skills. Preferred: advanced degrees (e.g., RN, PharmD), experience with device safety reporting, eTMF filing, and PV audits. High-value: experience supporting biologics or cell therapy product safety, clinical trial phases (indicate experience in early to late-stage development), regulatory compliance, and global safety database management. Work setup: remote with frequent travel to South San Francisco headquarters; hybrid onsite option available.