Director, Global Patient Safety Sciences - General Medicine

Regeneron seeks a Director of Global Patient Safety Sciences to lead pharmacovigilance strategy for assigned compounds across therapeutic areas. The role requires direct oversight of safety surveillance, signal management, regulatory communications, and cross-functional team representation in a matrix environment.

Responsibilities

• Lead global patient safety strategy and oversight for assigned compounds throughout asset lifecycle
• Manage safety surveillance, signal detection, and regulatory agency responses
• Chair Safety Monitoring Team activities and represent GPS on cross-functional strategic program teams
• Conduct medical review of complex adverse event reports and develop safety planning
• Mentor junior safety scientists and drive continuous improvement initiatives

Requirements

• 10+ years experience in pharmacovigilance, medical field, or drug safety with PSUR/DSUR/RMP expertise
• 5+ years relevant pharmacovigilance or medical experience with PharmD, PhD, or MD degree
• Demonstrated expertise in safety documents, benefit-risk assessment, and regulatory guidelines (FDA, EU, ICH)
• Ability to lead and develop diverse safety professional teams
• Strong cross-functional communication and influence skills in matrix environments
• Clinical experience or industry background in Oncology preferred