Global Patient Safety Senior Scientist Rare Diseases

Conduct scientific review and interpretation of safety data to prepare aggregate reports, manage Risk Management Plans, and drive signal detection and evaluation activities. Proactively monitor clinical trial documentation and SAE reporting to ensure timely regulatory compliance and accurate data reconciliation with Global Drug Development CROs. Deliver efficient medical monitoring by generating periodic line listings for DSURs and SUSARs, while providing oversight of pharmacovigilance Standard Operating Procedures and collaborating cross-functionally on product safety decisions. Lead a team of safety physicians and scientists as the assigned Safety Asset Lead, ensuring all safety profiles inform development milestones and benefit–risk evaluations.