Manager, Post-Marketing Pharmacovigilance

Role: Manager of Post-Marketing Pharmacovigilance overseeing drug safety for Celcuity’s approved product. Responsibilities: manage vendor oversight of end-to-end safety case processing, safety reporting (including PSUR/PBRER, PADER), and quality control; monitor vendor performance, ensure compliance with timelines, and maintain PV policies and SOPs. Serve as PV liaison internally and support safety database reconciliation. Qualifications: Bachelor's in life sciences or related; 4-6 years PV experience with emphasis on post-marketing safety; deep knowledge of FDA guidelines; experience with Argus preferred. HighValue: post-marketing safety, pharmacovigilance, FDA regulations, safety database management, safety reporting, vendor oversight. WorkSetup: not specified; likely office-based with possible flexibility.