Associate Director, Pharmacovigilance Operations

Role: Associate Director, Pharmacovigilance Operations, leading PV activities for CG Oncology's clinical and post-marketing safety efforts. Responsibilities include managing PV operations, ensuring compliance with FDA, EMA, ICH, GCP, and GVP standards, overseeing vendor governance, maintaining safety data integrity, supporting regulatory submissions, and advancing PV systems and launch readiness. This role collaborates closely with Clinical Development, Regulatory, Medical Affairs, QA, and external PV partners, serving as a key PV operations liaison. Qualifications: Bachelor's in Life Sciences, Nursing, Pharmacy, or related field; 10+ years in PV, drug safety, or clinical safety within biotech, pharma, or CRO environments; minimum 5 years in PV leadership and vendor oversight. Preferred experience includes oncology, particularly bladder cancer, immuno-oncology, or viral therapies, and supporting BLA/NDA submissions, audits, and inspections. High-Value: Focus on oncology therapeutics, clinical and post-marketing PV, regulatory compliance, inspection readiness, and vendor management within a global, remote-friendly environment.