Associate Director, Pharmacovigilance Operations

Role: Associate Director of Pharmacovigilance Operations overseeing global PV activities for CG Oncology's bladder cancer therapies. Responsibilities: lead PV operations and vendor oversight, ensure compliance with FDA/EMA/ICH GCP and GVP standards, manage safety data integrity, coordinate aggregate reporting, and support PV systems and infrastructure. Serve as PV liaison across functions, promote inspection readiness, and oversee PV documentation, audits, and quality systems. Qualifications: Bachelor's in Life Sciences, Nursing, Pharmacy, or related field; 10+ years in PV or drug safety, with 5+ years in leadership roles; experience with clinical trial safety, post-marketing PV, and vendor management; oncology experience preferred, including immuno-oncology, intravesical therapy, or oncolytic platforms. High-Value: focus on bladder cancer, immunotherapies, BLA/NDA support, clinical and post-marketing PV, regulatory compliance, PV systems management, and vendor governance. Work setup: Fully remote; no specific travel requirements noted.