Associate Patient Support Program Safety & PV Oversight Director

Role: Associate Patient Support Program Safety & PV Oversight Director, responsible for managing safety data exchange, compliance, and oversight across all Patient Support Programs (PSPs) and devices. Responsibilities include providing strategic leadership on safety governance, ensuring adherence to global regulations, overseeing quality assurance processes, and managing stakeholder interactions related to adverse effect reporting. The role involves developing training, overseeing reconciliation and audit processes, and ensuring inspection readiness. Qualifications: Bachelor's degree in healthcare or life sciences with 12+ years in pharmacovigilance (or 10+ years with a Master’s, or 7+ with a PharmD), including extensive experience in end-to-end case processing of ICSRs and call center management. Skills include knowledge of GxP regulations, safety databases (e.g., Argus), and strong stakeholder management abilities. Preferred: advanced degrees such as BSN, Master’s, PharmD, RN licensure, and prior product development or postmarketing experience. HighValue: focus on pharmacovigilance, safety data exchange, compliance, and inspection readiness within a biopharma setting. WorkSetup: fully onsite in Morrisville, NC.