Director, Patient Safety Scientist

Director, Patient Safety Scientist responsible for shaping and leading safety signal detection, risk management, and regulatory safety strategy across the product lifecycle. Independently oversees signal evaluation activities, prepares safety sections for regulatory documents (DSUR, PBRER, PADER), and develops responses to health authority queries. Leads cross-functional safety initiatives, mentors junior scientists, and collaborates with SMT/ACT stakeholders to influence decision-making for assets in development and marketed products. Demonstrates deep expertise in pharmacovigilance, data synthesis of clinical/nonclinical/postmarketing data, and use of AI/automation tools to enhance safety analytics, while ensuring compliance with global regulatory safety standards. Demonstrates strong medical writing capabilities for safety and risk management sections of regulatory filings and supports safety labeling updates and postmarketing safety programs. Emphasizes leadership, collaboration, adaptability, and the ability to translate complex data into actionable risk management strategies across global teams.