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/pharmacovigilance within the pharmaceutical or biotechnology industry regarding pharmacovigilance safety databases (e.g., Argus, ARISg), safety reporting systems, and data analysis tools.
• Strong analytical, problem-solving, and decision-making skills, with the ability to interpret complex safety data to make informed decisions.
• A history of progressive leadership responsibilities.
• In-depth knowledge of global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH).
• Strong leadership and management skills, with a track record of building and developing high-performing teams.
• Excellent written and verbal communication, interpersonal, and influencing skills, with the ability to effectively collaborate with internal and external stakeholders.
• Proven ability to think strategically, drive innovation, and implement process improvements.
• Experience interacting with regulatory agencies and participating in regulatory inspections and audits is required.
• Expert knowledge of US, EU, and global regulations governing pharmacovigilance.
• Strong program management skills enabling efficient planning and execution of program milestones within budget and timelines.
• Strong vendor management skills with experience managing high profile projects with vendors and internal staff.
• Ability to build relationships and influence across disciplines, functions, and levels.
• Strong learning orientation regarding industry best practices and the desire to share expertise and learn from others.
• Commitment to patients and the science that drives the shared mission at Revolution Medicines.

Preferred Skills:

• Advanced degree in computer science, pharmacy, medicine, nursing, life sciences, or a related field preferred.

The base salary range for this full-time position is $256,000 to $320,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.

#LI-Hybrid #LI-GL1