Senior Director, Global Patient Safety Surveillance

Revolution Medicines seeks a Senior Director for Global Patient Safety Surveillance in Basel to lead PV processes, ensure regulatory compliance, and mentor a global team within a late-stage oncology company.

Revolution Medicines, a late-stage clinical oncology firm focused on targeted therapies for RAS-addicted cancers, needs a senior leader to direct its Global Patient Safety Surveillance efforts. In this enabling and strategic role, the individual will act as a line leader and subject matter expert, overseeing the design, maintenance, and execution of core safety processes to ensure the continuous delivery of effective scientific and pharmacovigilance activities.

Responsibilities

• Lead, mentor, and hold accountable an experienced global team responsible for building and maintaining safety processes.
• Provide expert guidance on the design, development, and support of core Global Patient Safety processes in compliance with GCP, GVP, and GDocP standards.
• Direct the GPS team and cross-functional staff to manage safety workflows and ensure timely delivery of required outputs.
• Offer strategic consultation to Development and filing teams on PV-related aspects of regulatory reports and clinical study documents.
• Collaborate with the EU Qualified Person Responsible for Pharmacovigilance to maintain European regulatory compliance.
• Develop and sustain a PV quality system that demonstrates quality, effectiveness, and control in alignment with global regulations.
• Maintain inspection readiness by ensuring processes and training meet global regulatory requirements.
• Manage resources, budgets, and oversight of PV contract research organizations for relevant safety activities.
• Cultivate a culture of safety, compliance, and continuous improvement across the GPS team and the broader organization.

Requirements

• Advanced degree in Medicine, Pharmacy, or a related health professional field (MD, PharmD, PhD/MSc, etc.).
• At least 12 years of experience in pharmacovigilance or a related area within the pharmaceutical or biotechnology sector.
• Minimum 6 years of people management experience.
• Demonstrated leadership track record in pharmacovigilance.
• Proven experience interacting with regulatory authorities such as the FDA or EMA, including participation in type C, B, pre-BLA/MAA meetings, advisory committees, or scientific advice forums.
• Deep understanding of global PV regulations and guidelines, including ICH and GxP standards, with a strong record of compliance.

Nice to have

• Experience with advanced safety data analytics and PV systems.
• Ability to lead, manage, and influence complex projects in a matrixed organization.
• Proficiency in managing regulatory interactions.
• Experience with BLA/MAA submissions.

About the company

Revolution Medicines is a late-stage clinical oncology company dedicated to developing novel targeted therapies for patients with RAS-addicted cancers. The organization is committed to addressing the needs of patients with cancers harboring mutations in the RAS signaling pathway and fosters a culture of safety, compliance, and continuous improvement.

• Commitment to patients with cancers harboring mutations in the RAS signaling pathway.
• Fosters a culture of safety, compliance, and continuous improvement.