Director, Global Patient Safety Operations

The Opportunity:

We are seeking a highly skilled and experienced Director of Global Patient Safety Operations to join our team. Reporting to the Head of Global Patient Safety Operations, this role provides leadership and oversight of safety operations, including management of pharmacovigilance vendors and serving as an internal subject matter expert. The Director will mentor and develop direct reports, execute the department’s vision and strategy, and work collaboratively with cross-functional teams. In addition, the Director will collaborate cross-functionally to continuously develop and maintain the pharmacovigilance system to support Revolution Medicines’ research, development, and marketed products.

• Lead and manage direct reports of the Global Patient Safety Operations team

• Oversee procedures related to Individual Case Safety Report processing, oversight of metrics, and compliance with global safety reporting requirements.

• Oversee pharmacovigilance vendors and CROs, ensuring quality, budget, and timely delivery of safety operations activities.

• Develop and maintain the pharmacovigilance system and processes, including SOPs, PSMF, and inspection readiness activities.

• Work collaboratively and cross-functionally to ensure timely and accurate completion of expedited and periodic reports (e.g., DSUR, PBRER), aggregate safety reports, and REMS/RMP analyses, and other safety deliverables.

• Review and provide input for regulatory reports and clinical study documents (e.g., protocols, CRFs, ICFs, Investigator Brochures, ISS/ISE, labeling, CCSIs) as applicable.

• Collaborate cross-functionally with Clinical Development, Clinical Operations, Data Science, Regulatory, Quality, and Medical Affairs.

• Partner with the EU QPPV to ensure European compliance and maintain PV agreements (PVAs, SDEAs) with partners.

• Build and mentor a high-performing team while driving operational excellence and process improvements.

• Represent Global Patient Safety Operations with senior leadership and regulatory agencies, influencing pharmacovigilance strategy and direction.

Required Skills, Experience, and Education:

• Bachelor’s degree required. Advanced degrees in pharmacy, medicine, nursing, life sciences, or a related field are preferred.

• Experience (8+ years) in drug safety/pharmacovigilance within the pharmaceutical or biotechnology industry, with knowledge of safety operations, GCP, GVP, clinical trial conduct, data interpretation, process management, quality management, and safety’s role in clinical development.

• 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 in drug safety operations.

• Experience interacting with regulatory agencies and participating in regulatory inspections and audits is required.

• Expert knowledge of US, EU, and global regulations governing pharmacovigilance.

• Expert knowledge of industry standard safety databases.

• 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 CROs and internal staff.

• Ability to build relationships and influence across disciplines, functions, and levels.

• Strong learning orientation 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:

• Experience with the implementations of pharmacovigilance systems.

• Demonstrated ability to manage complex projects and work effectively in a matrixed organization.

• Proficiency in managing regulatory inspections and interactions.

• Strong organizational and time management skills, with the ability to prioritize and manage multiple tasks effectively.

• Excellent influence and collaboration/teamwork capabilities. 

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