Associate Director, Pharmacovigilance Operations

Role: Associate Director, Pharmacovigilance Operations, overseeing global PV activities for CG Oncology's bladder cancer therapies. Responsibilities include managing PV operations, ensuring compliance with GxP standards, overseeing vendor relationships, maintaining inspection readiness, and supporting safety data integrity and regulatory submissions. Key focus areas involve clinical trial and post-marketing safety activities, PV system management, and safety governance. Requirements: Bachelor's in Life Sciences or healthcare; 10+ years in PV, drug safety, or clinical safety within biotech, pharma, or CROs; 5+ years in PV leadership, vendor oversight, and regulatory compliance; oncology experience preferred, including BLA/NDA support, safety, and PV system expertise. High-value specifics include oncology modalities (immuno-oncology, intravesical therapy), clinical and post-marketing phases, and regulatory preparedness. Collaboration spans Clinical Development, Regulatory, Medical Affairs, Quality, IT, and external PV vendors. Location: Fully remote; no travel specified.