Executive Director, Medical Safety Assessment Therapeutic Lead, Neuroscience

Position Responsibilities General Product Support Oversee safety activities and benefit-risk strategies for assigned compound(s)/program(s); chair product/TA Safety Management Team (SMT). Review/approve aggregate safety documents (e.g., DSUR, PBRER) and safety sections of clinical/trial documents and regulatory filings. Lead signal evaluation/management across data sources; ensure documentation (e.g., Safety Topic Review/Signal Report). Approve safety labeling; provide safety subject matter expertise for regulatory labeling. Support qualified person activities (e.g., EU QPPV) and provide safety input to R&D publications/presentations. Clinical Development Oversee global safety strategy; support submission document production and review final summary documents. Oversee medical safety development and benefit-risk management execution. Review safety input to study plans/protocols/amendments/IB/SAP/ICF/CSR and authority/IRB queries. Drive safety risk language and risk management strategy. Postmarketing Support Oversee lifecycle safety strategy and global postmarketing safety submissions/studies. Approve DSUR/PBRER and support RMP execution; lead safety signal evaluation and regulatory responses. Ensure labeling reflects emerging postmarketing safety. Department/Cross-functional/Leadership Drive process change, support inspections, manage issue/crisis response, liaise cross-functionally, hire/mentor staff. Identify data gaps, train employees, support due diligence/licensing input, act as TA liaison, support manufacturing quality and safety communications. Qualifications/Requirements MD/equivalent required; postgraduate training/experience in internal medicine, immunology, oncology, or related desirable. 7+ years in pharmacovigilance (or relevant pharma/biomedical field) strongly preferred; management experience strongly preferred. Key Competency Requirements Drug development lifecycle knowledge; PV expertise; regulatory safety assessment/action knowledge; analytical reasoning; attention to detail; ability to manage multiple complex projects; strong communication. Travel Occasional US travel (e.g., every 2–3 months) and overseas travel (e.g., about once/year). Compensation/Benefits (if applicable) $334,860–$405,769 base; additional incentive cash/stock may be available. Health coverage; wellbeing programs; 401(k), disability/life insurance, and other protections; paid time off (details vary by location/employment type). #J-18808-Ljbffr