Director, Global Patient Safety Operations

Director Of Global Patient Safety Operations

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity :

We are seeking a highly skilled and experienced Director of Global Patient Safety Operations to join our team. Reporting to the Head of Global Patient Safety Operations, this role provides leadership and oversight of safety operations, including management of pharmacovigilance vendors and serving as an internal subject matter expert. The Director will mentor and develop direct reports, execute the department's vision and strategy, and work collaboratively with cross-functional teams. In addition, the Director will collaborate cross-functionally to continuously develop and maintain the pharmacovigilance system to support Revolution Medicines' research, development, and marketed products as well as :

• Lead and manage direct reports of the Global Patient Safety Operations team.
• Oversee procedures related to Individual Case Safety Report processing, oversight of metrics, and compliance with global safety reporting requirements.
• Oversee pharmacovigilance vendors and CROs, ensuring quality, budget, and timely delivery of safety operations activities.
• Develop and maintain the pharmacovigilance system and processes, including SOPs, PSMF, and inspection readiness activities.
• Work collaboratively and cross-functionally to ensure timely and accurate completion of expedited and periodic reports (e.g., DSUR, PBRER), aggregate safety reports, and REMS / RMP analyses, and other safety deliverables.
• Review and provide input for regulatory reports and clinical study documents (e.g., protocols, CRFs, ICFs, Investigator Brochures, ISS / ISE, labeling, CCSIs) as applicable.
• Collaborate cross-functionally with Clinical Development, Clinical Operations, Data Science, Regulatory, Quality, and Medical Affairs.
• Partner with the EU QPPV to ensure European compliance and maintain PV agreements (PVAs, SDEAs) with partners.
• Build and mentor a high-performing team while driving operational excellence and process improvements.
• Represent Global Patient Safety Operations with senior leadership and regulatory agencies, influencing pharmacovigilance strategy and direction.

Required Skills, Experience, and Education :

Preferred Skills :