Pharmacovigilance Operations Manager

Role: Pharmacovigilance Operations Manager overseeing CG Oncology’s global PV activities, focusing on clinical trial safety operations, vendor management, and maintaining an inspection-ready PV system. Responsibilities include managing external safety vendors and CRO relationships, monitoring vendor performance, ensuring compliance with GxP and regulatory standards, supporting audits and inspections, and collaborating with Clinical Operations, Regulatory, and Quality teams on safety data flow and risk management. The role involves process improvement, documentation, and providing PV training. Qualifications: Bachelor's in life sciences or related field, minimum 5 years in PV operations within clinical development, with at least 4 years’ oncology experience (preferably NMIBC or GU Cancer), and 3+ years in leadership or vendor management. Preferred: clinical bedside care experience, advanced degree, and strong knowledge of global PV regulations (ICH, FDA, EMA). High-Value: oncology (bladder cancer focus), PV process management, vendor oversight, GxP compliance, remote work with quarterly travel. The role supports a fast-growing biopharma developing immunotherapies for bladder cancer, emphasizing operational excellence and regulatory compliance in a remote work environment.