Executive Director, Medical Safety Assessment Therapeutic Lead, Neuroscience

Position Summary Provide strategic oversight and delivery of medical safety assessment for assets in a therapeutic area by effectively managing a safety physician team. Oversee safety activities and benefit-risk strategies for assigned compounds/programs; chair the product/TA Safety Management Team (SMT). Oversee, review, and approve aggregate safety review documents and safety sections of clinical trial documents and regulatory filings. Oversee signal evaluation/management from any data source; guide signal evaluation strategy and ensure required documentation. Approve safety labeling activities; provide safety subject matter expertise for regulatory labeling. Drive process change and maintain state‑of‑the‑art PV processes. Responsibilities (high level) Global safety strategy in development; oversee safety risk language, risk management strategy, and pre‑filing safety activities. Ensure review of DSURs, annual reports, and periodic safety submissions; represent WWPS at health authority meetings. Lifecycle/postmarketing safety oversight, submissions, risk management plan (RMP) elements, and safety signal reporting. Support regulatory inspections; issue/crisis management; patient safety team collaboration; hire/mentor staff. Qualifications/Required Skills MD/equivalent required. 7+ years in pharmacovigilance or relevant pharmaceutical/biomedical field strongly preferred; management experience strongly preferred. Extensive drug development understanding; expert PV and regulatory safety requirements; strong scientific/analytical reasoning; attention to detail; ability to manage multiple complex projects; excellent written/verbal communication. Travel Occasional US travel (about once every 2–3 months) and overseas travel (about once a year). Compensation/Benefits (explicit) $334,860 – $405,769. Health coverage; wellbeing programs; 401(k) and other financial protection benefits; paid time off (flexible time off/annual vacation and holidays; eligibility varies by location). #J-18808-Ljbffr