Principal Scientist, Safety Surveillance (Pharmacovigilance)

About the role

Revolution Medicines, a global oncology company focused on RAS-addicted cancers, is looking for a Principal Scientist of Safety Surveillance to join its Surveillance team. As a lead subject matter expert, the role leads and contributes to the design, development, maintenance and support of core Global Patient Safety (GPS) processes, covering risk management, signal detection and management, comparative benefit-risk and aggregate reporting. It also supports the delivery of effective scientific safety and pharmacovigilance activities in line with health authority and internal stakeholder requirements.

Key responsibilities

• Serve as lead subject matter expert for core GPS processes (comparative benefit-risk, signal detection and management, risk management, aggregate reporting) in compliance with GCP, GVP and GDocP.
• Manage the assigned safety processes and deliver outputs such as Risk Management Plans, DSURs and PSURs in line with global regulatory requirements.
• Advise development and filing teams on PV parts of regulatory reports, clinical study documents and labeling strategy.
• Lead the development of controlled documentation for PV aggregate reporting and other processes, and work with the EU QPPV to ensure European compliance.
• Contribute to a PV quality system, ensure inspection readiness and act as SME for audits and inspections.
• Propose and implement improvements to safety capabilities, share good practice and build partnerships with internal and external partners.
• Keep abreast of regulatory changes, communicate safety information clearly and partner with PV systems personnel on PV systems.

Required profile

• Advanced degree in Medicine, Pharmacy or a related field (MD, PharmD, PhD/MSc or equivalent).
• At least 10 years of experience in PV or a related field in pharma or biotechnology.
• Proven leadership in PV and in-depth knowledge of global PV regulations and guidelines (ICH, GxP).
• Strong analytical, strategic and decision-making skills, and excellent communication and team management abilities.

Preferred skills

• Experience with advanced safety data analytics and PV systems.
• Ability to manage complex projects in a matrixed organization and proficiency in regulatory interactions.
• BLA/MAA experience.