Executive Director, Global Patient Safety Systems (Pharmacovigilance)

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 Head of Global Patient Safety Systems to join our dynamic team. The Executive Director of Global Patient Safety Systems provides leadership and oversight to the Global Patient Safety (GPS) department through management of safety systems within Global Patient Safety. This role involves strategic planning, resource management, and oversight of all safety systems technologies, ensuring compliance with global regulatory requirements.

The successful candidate will be a self-starter, proactive, detail oriented, and creative thinker who will lead and build our Global Patient Safety Systems department, overseeing all aspects of Revolution Medicines safety systems including the implementation, management, maintenance, and integration of pharmacovigilance software and IT systems in support of our drug products throughout their lifecycle; oversight and management of pharmacovigilance vendors, and will serve as an internal subject matter expert for Pharmacovigilance IT systems. This critical role will involve strategic leadership, collaboration with cross-functional teams, technical expertise, and vendor management skills to ensure compliance with regulatory requirements to safeguard patient well-being, development of compliant safety policies, and the development of a best-in-class pharmacovigilance system. The successful candidate will draw upon their experience to:

• Provide leadership, administrative oversight, and management of the Global Patient Safety Systems team, fostering a collaborative and efficient work environment.

• Develop and implement strategic plans for the Safety Systems department, aligning with the overall goals of GPS.  

• Oversee the implementation, maintenance, and enhancement of safety systems technologies, including both internal systems and vendor-provided solutions, including signal detection and data visualization applications.

• Ensure all safety systems and processes comply with global regulatory requirements including FDA, EMA, and other relevant authorities.

• Manage relationships with safety system vendors, ensuring high-quality service, and regulatory compliance.

• Assist in the collection, analysis, and interpretation of safety data, ensuring accurate and timely reporting of adverse events.

• Identify and drive continuous improvement in safety systems operations through innovative technology solutions and process enhancements.

• Work collaboratively with safety operations, safety science, and other departments to ensure PV system compliance and best in class operations.

• Collaborate with internal and external stakeholders, including clinical development, regulatory affairs, and other departments, to ensure effective communication and coordination of safety information.

• Ensure proper safety systems training is developed to ensure the global safety database configuration is appropriate to meet Revolution Medicines needs. 

• Ensure safety systems specifications in preparation of aggregate safety reports required by health authorities. 

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

• Lead development of standard operating procedures for safety and internal compliance. 

• Ensure safety database processes are optimized for reconciliation with the clinical databases.

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

• Responsible for ensuring inspection readiness for global inspections by ensuring all processes and training reflect global regulatory requirements.

• Develop and maintain emergency response plans (i.e. business continuity plans).

Required Skills, Experience and Education:

• Bachelor’s degree required.

• Extensive experience (15+ years) in drug safety/pharmacovig