Description

We are seeking a Director, Pharmacovigilance Operations who will report to the Executive Director, Drug Safety and Pharmacovigilance. You will lead and oversee the global Pharmacovigilance (PV) operational infrastructure. This role is responsible for the oversight of outsourced safety/pharmacovigilance activities, vendor oversight, and operational compliance across Celcuity’s post-marketing program. The Director will play a pivotal role in scaling PV operational capabilities, ensuring inspection readiness, maintaining regulatory compliance, and contributing to strategic safety planning. Responsibilities include overseeing end-to-end ICSR collection, processing, reconciliation, and reporting of post-marketing cases; ensuring global compliance with pharmacovigilance regulations; providing oversight of the PV vendor activities; and supporting development of internal PV policies and training programs, among other duties.

Requirements

Bachelor’s degree in Life Sciences, Pharmacy, Nursing or related field. Minimum of ten (10) years of post-marketing safety experience at a biotech or pharmaceutical company. Strong experience managing CRO/vendor relationships. Deep understanding of PV regulations and reporting requirements (e.g. FDA, EMA, MHRA, etc.). Excellent written and verbal communication skills. Strong interpersonal skills. Attention to detail. Strong technical and analytical skills with advanced knowledge of MS Office. Extensive experience with commercial safety databases such as Oracle Argus or ARISg. Continuous improvement mindset; flexible and willing to learn.