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Gaithersburg, MD, Radnor, PA, Oxford, UK
Regulatory Affairs
The Associate Director, Safety Operations is a key operational leader responsible for the execution and management of global pharmacovigilance operations. Reporting to the Director of PV Operations, the Associate Director ensures the seamless delivery of case management, regulatory reporting, and operational compliance across clinical and post-marketing portfolios.
This role serves as the primary operational interface for PV vendors and cross‑functional study teams. The Associate Director is an emerging expert who translates the functional strategy into actionable operational plans, manages complex technical issues with limited guidance, and ensures that the hands‑on elements of the PV system are robust, scalable, and inspection‑ready.