Director, Global Patient Safety Operations

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 professionals 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 Director of Global Patient Safety Operations to join our dynamic team. The Director of Global Patient Safety Operations provides leadership and oversight to the Global Patient Safety department, including implementing the Safety database, overseeing pharmacovigilance vendors, and serving as an internal subject matter expert, furthering the development and implementation of the pharmacovigilance system in support of Revolution Medicines research, development and marketed products. 

The successful candidate will take a leadership role in our Safety Operations department, overseeing the safety case processing and management of the department in support of our drug products throughout their lifecycle. This role will involve strategic leadership, management of direct reports, collaboration with cross-functional teams, technical expertise, and vendor management skills to ensure compliance with regulatory requirements to safeguard patient well-being.

• In collaboration with senior leadership, develop and implement the Revolution Medicines safety operations strategy, vision, and direction, including the safety database strategy. 

• In collaboration with senior leadership, manage the safety operations team ensuring case processing activities from all sources follow global regulations and internal requirements, create and analyze oversight metrics reports, review, approve, and trend late case investigations, ensure proper training is received and documented, and ensure the global safety database configuration is appropriate to meet Revolution Medicines needs. 

• In collaboration with senior leadership, manage the resourcing, budget, and oversight of pharmacovigilance contract research organizations (PV CROs) regarding safety operations activities.

• Partner with safety science and other development staff as necessary for medical review and approval of cases inclusive of case narratives and causality assessments of AE/SAE reports. 

• In collaboration with safety science and other development staff, compile analysis of similar events (AOSE), individual case comments, REMS (Risk Evaluation and Mitigation Strategies), RMP (Risk Management Plan) analyses, and ad hoc safety analysis as required by health authorities or corporate policy. 

• Contribute to the preparation of aggregate safety reports required by health authorities. 

• Author, review and provide input and approval for drug-safety related regulatory reports and clinical study documents (including case report forms, clinical study protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), product package labeling, Company Core Safety Information. 

• Develop and maintain relationships across Revolution Medicines, particularly in Clinical Operations, Clinical Development, Clinical Data Science, Regulatory Affairs, Quality Assurance, Medical Affairs, and other departments as appropriate. 

• Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal time frames and time frames dictated by regulatory authorities. 

• In collaboration with senior leadership, develop standard operating procedures for safety and internal compliance. 

• Oversee as applicable, safety vendors responsible for drafting and submitting periodic reports such as the DSUR (Development Safety Update Report) and PBRER (Periodic Benefit Risk Evaluation Report), ensuring compliance with regulations and timeliness of submission. 

• Collaborate with Safety Science to create robust processes to maintain compliance with safety requirements related to REMS/RMP.

• In conjunction with the clinical data science and clinical operations, coordinate periodic reconciliation of the clinical and safety databases. 

• Create and maintain the Pharmacovigilance System Master File (PSMF) to support European filings and regulations as applicable.

• Work with the EU Qualified Person Responsible for Pharmacovigilance (QPPV) to ensure European compliance as applicable.

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