Global Pharmacovigilance Safety, Senior Manager- Obesity

Direct aggregate report planning, preparation, writing, and review while organizing liaison activities with affiliates and internal partners. Lead safety oversight for clinical trials by reviewing protocols, statistical analysis plans, and adverse event data, including signal detection, evaluation, and management through data analysis and result documentation. Develop safety-related data collection forms, draft safety assessment reports and regulatory responses, and prepare presentations for cross-functional decision-making bodies. Contribute to risk management strategy development, risk minimization activity tracking, and new drug application filings. Maintain inspection readiness per the PV System Master File and serve as the point of contact for Health Authority inspections and internal process audits.