Vice President, Global Patient Safety Surveillance

Revolution Medicines•Redwood City, CA

5d•Hybrid

About The Position

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. 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 Vice President of Safety Surveillance to join our dynamic team. The Vice President of Safety Surveillance is a senior executive responsible for the leadership, oversight, strategy, and execution of a portfolio of pharmacovigilance (PV) processes supporting both development and post-market pharmacovigilance requirements. In particular, the release of the European Medicines Agency (EMA) Good Pharmacovigilance Practice (GVP) Modules has resulted in increased requirements for sponsors to maintain inspection-ready processes and procedures that address risk management, aggregate reporting, signal detection, and benefit-risk assessment. These requirements include the establishment of a set of quality standards that will enable monitoring and management of process effectiveness over the drug’s lifecycle. In partnership with Safety Science personnel, the VP Safety Surveillance will establish a pharmacovigilance system that will enable efficient and compliant execution of PV processes while also providing scientific insights on our portfolio compounds that enable maximization of benefit-risk for patients. This will lead to timely and accurate communication of important safety information allowing health authorities, prescribers, and patients to ensure safe use of Revolution Medicine’s products in the development and post-market settings. Additionally, through the proper management and execution of these processes, Global Patient Safety (GPS) will be able to demonstrate oversight and control of the PV system for all stakeholders. This critical role will require strategic, scientific and clinical leadership, managerial expertise to build a high-functioning team, communication, collaboration with cross-functional teams, technical expertise, experience and understanding of global pharmacovigilance regulations, and vendor management skills to ensure compliance with regulatory requirements to safeguard patient well-being.

Requirements

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.

Nice To Haves

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.

Responsibilities

Pharmacovigilance Aggregate Reporting
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.
Risk Management
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.
Benefit-Risk
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.
Signal Detection
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.
Global Product Safety Leadership, Collaboration, Influence, Compliance, and Technical Expertise
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.