Pharmacovigilance Operations Manager

Role: Pharmacovigilance (PV) Operations Manager overseeing global safety activities at CG Oncology, focusing on clinical trial safety and post-market PV. Responsibilities: manage external safety vendors, ensure PV system compliance and inspection readiness, oversee safety data flow, contribute to audits and regulatory inspections, and support process improvements. Requirements: bachelor’s in life sciences or related field; 5+ years in PV operations, with 4+ years in oncology, and experience managing vendors and ensuring GxP compliance. Preferred: clinical healthcare background (RN, NP, PA), oncology experience in NMIBC or GU cancers, and leadership in PV. High-Value: oncology therapeutics, GxP environment, global PV regulations (ICH, FDA, EMA), remote work with quarterly travel, and cross-functional collaboration with Clinical Operations, Regulatory, and Quality teams.