Revolution Medicines · 1 day ago
Vice President, Global Patient Safety Surveillance
San Francisco Bay Area
Full-time
Onsite
Director/Executive
$284K/yr - $355K/yr
20+ years expRevolution Medicines is a clinical-stage precision oncology company focused on developing targeted therapies for RAS-addicted cancers. They are seeking a Vice President of Safety Surveillance to lead pharmacovigilance processes, ensuring compliance with global regulations and effective communication of safety information.
Health CareLife ScienceMedical
Responsibilities
Develop and implement the global pharmacovigilance (PV) aggregate reporting strategy in compliance with Good Clinical Practice (GCP), Good Vigilance Practice (GVP), and Good Documentation Practices (GDocP) in alignment with the company’s mission and objectives
Provide strategic direction and leadership to the Global Patient Safety (GPS) team and cross-functional Development staff to manage the process, and preparation of high-quality PV aggregate reports (i.e. DSUR, PSUR/PBRER, PADER) required by health authorities, ensuring accuracy, timely completion, and submission in compliance with global regulatory requirements and following best practices
Collaborate and cooperate with Regulatory Medical Writing to ensure consistency in writing style and process
Oversee the resourcing, budget, and management of PV contract research organizations (PV CROs) in aggregate reporting activities as needed
Lead development of controlled documentation required to demonstrate control and oversight of the PV aggregate reporting process and other processes as needed
Work with the EU Qualified Person Responsible for Pharmacovigilance (QPPV) to ensure European compliance as applicable
Contribute to the development and maintenance of a PV quality system in line with global regulations (i.e. GCP, GVP) enabling demonstration of quality, effectiveness, and control
Ensure inspection readiness for global inspections related to PV processes under management by ensuring processes and training reflect global regulatory requirements as applicable. Act as subject matter expert (SME) for audit and inspection
Foster a culture of safety, compliance, and continuous improvement within the PV function and broadly across the organization
Promote continuous professional development and ensure the team is equipped with the latest regulatory intelligence related to aggregate reporting and GDocP
Oversee PV risk management practices for GPS ensuring compliance with global regulations as it pertains to the risk management process and development of Risk Management Plans (RMPs), additional Risk Minimization Measures (aRMMs), and Risk Evaluation Mitigation Strategies (REMs) as applicable across the development and marketed products portfolio
In partnership with Regulatory Labeling, Safety Science, and cross-functional stakeholders, contribute to the development of Company Core Safety Information (CCSI), Company Core Data Sheet (CCDS), and local labels
Develop and maintain relationships across Revolution Medicines, particularly in Clinical Operations, Clinical Development, Clinical Data Science, Regulatory Affairs, Quality Assurance, Medical Affairs, Commercial, and other departments as appropriate to ensure compliance with PV risk management measures and ensure an integrated PV system
Develop a cross-functional center of excellence focused on the establishment of a set of structured benefit-risk (sBR) methodologies and tools that can be utilized across the development life-cycle
In partnership with cross-functional development colleagues, integrate sBR processes into the development teams in order to enable a Company Core BR position for each clinical development candidate at defined development milestones
In partnership with Safety Science, and Safety Systems, develop a strategy and process for signal detection that is applicable across the development life-cycle and compliant with post-market global requirements
Establish a cross-functional assessment and adjudication mechanism that enables efficient signal management from identification to closure
Drive development of controlled documentation for GPS sponsored processes as applicable and ensure that Safety’s voice is heard in cross-functional settings
Provide expert consultation and direction for Development and filing teams as it relates to PV portions of regulatory reports and clinical study documents (including Clinical Protocols, Informed Consent Forms, Investigator Brochures, NDA filing packages (i.e. Module 2: Clinical Overview, Clinical Summary, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), safety narratives), and labeling strategy
Build, mentor, and lead a high-performing global PV team
Ensure clear and effective communication of safety information to internal and external stakeholders
Provide expertise in development and approval of PV agreements (PVAs) and safety data exchange agreements (SDEA) with applicable partners as they pertain to safety activities
Partner with PV systems personnel in the development and implementation of fit for purpose PV systems
Qualification
Required
Advanced degree in Medicine, Pharmacy, or a related field (MD, PharmD, PhD preferred)
Minimum of 20 years of experience in PV or related field within the pharmaceutical or biotechnology industry
Minimum of 15 years of experience managing people; strong people management skills, willingness to help others, and ability to deal with ambiguity
Proven track record of leadership in PV
Experience and success in interacting with Regulatory Authorities (i.e. FDA, EMA) at type C, B, pre-BLA/MAA meetings, Advisory Committee meetings, or other scientific advice forums
In-depth knowledge of global PV regulations and guidelines (i.e. ICH, GxP) and a record of compliance with these standards
Strong analytical and strategic thinking, problem-solving, and decision-making skills
Excellent communication, collaboration, and team management abilities, enabling exertion of strong and successful influence of senior executives as well as strong external representation for the company
Technical expertise in PV
Strong clinical leadership and experience
Outstanding emotional intelligence
Proven ability to lead and develop PV personnel
Preferred
Experience with advanced safety data analytics and PV systems
Demonstrated ability to manage complex projects and work effectively in a matrixed organization
Proficiency in managing regulatory interactions
Strong organizational and time management skills, with the ability to prioritize and manage multiple tasks effectively
Excellent influence and collaboration/teamwork capabilities
BLA/MAA experience
Benefits
Competitive cash compensation
Robust equity awards
Strong benefits
Significant learning and development opportunities
Company
Revolution Medicines
Revolution Medicines is an innovative and dynamic organization of expert biologists, chemists, pharmacologists, clinical scientists.
501-1000 employees
H1B Sponsorship
Revolution Medicines has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (18)
2023 (15)
2022 (8)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$2.25BKey Investors
Royalty PharmaBoxer CapitalNextech Invest
2025-06-24Post Ipo Debt· $250M
2024-12-02Post Ipo Equity· $750M
2023-03-02Post Ipo Equity· $323.6M
Leadership Team
Luan Wilfong
Chief Human Resources Officer
Steve Kelsey
President
Recent News
2025-12-18
2025-12-18
Company data provided by crunchbase