Pharmacovigilance Operations Manager

Role: PV Operations Manager overseeing global pharmacovigilance activities for CG Oncology, focusing on clinical trial safety and post-market surveillance. Responsibilities include managing external safety vendors, ensuring PV system compliance, supporting audit and inspection readiness, and collaborating with Clinical Ops, Regulatory, QA, and other teams to facilitate safety data flow and risk management. Also responsible for process optimization, documentation, and training related to PV processes. Qualifications: Bachelor's in life sciences or related field, minimum 5 years of PV operations experience, with at least 4 years in oncology (NMIBC or GU cancers highly preferred). Experience leading PV teams or vendor management for at least 3 years, with strong knowledge of global PV regulations (e.g., ICH, FDA, EMA). Preferred: clinical bedside healthcare background (RN, NP, PA), oncology-specific PV expertise, and experience in GxP-regulated environments. High-value biopharma specifics: focus on oncology, bladder cancer, immunotherapies, and clinical safety operations. Work setup: Fully remote with quarterly travel to corporate offices.