Executive Director, Global Patient Safety Surveillance

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 scientists 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 Executive Director of Safety Surveillance to join our dynamic team. The Executive Director of Safety Surveillance is a senior executive responsible for the leadership, oversight, strategy, and execution of the pharmacovigilance aggregate reporting process and risk management as it pertains to communication and coordination of risk management activities in partnership with safety science in support of Revolution Medicine’s products over the product development life cycle. The Executive Director of Safety Surveillance will ensure that high quality aggregate reporting and risk management practices will enable compliance with global regulations demonstrating oversight of the pharmacovigilance system. 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.

This critical role will require strategic, scientific and clinical leadership, 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.

Responsibilities include:

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, production, and preparation of high-quality PV aggregate reports (i.e. DSUR, PSUR) 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 aggregate reporting 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 e