Revolution Medicines
Director, Global Patient Safety Operations
Revolution Medicines, San Francisco, California, United States, 94199
Overview
Director, Global Patient Safety Operations Join to apply for the
Director, Global Patient Safety Operations
role at
Revolution Medicines . 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 Revolutionaries 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 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.
Responsibilities
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.
Collaborate 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 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.
Qualifications
Bachelor’s degree required. Advanced degrees in pharmacy, medicine, nursing, life sciences, or a related field are preferred.
Experience (10+ 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.
Compensation and Equity The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. Base pay salary range is one part of the overall total rewards program and will be adjusted for the local market. Individual base pay is determined by role, level, location, skills, experience, and education. This position’s total rewards package includes competitive cash compensation, equity awards, benefits, and opportunities for professional development.
Base Pay Salary Range: $204,000 — $255,000 USD
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.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination.
#J-18808-Ljbffr
Director, Global Patient Safety Operations Join to apply for the
Director, Global Patient Safety Operations
role at
Revolution Medicines . 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 Revolutionaries 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 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.
Responsibilities
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.
Collaborate 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 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.
Qualifications
Bachelor’s degree required. Advanced degrees in pharmacy, medicine, nursing, life sciences, or a related field are preferred.
Experience (10+ 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.
Compensation and Equity The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. Base pay salary range is one part of the overall total rewards program and will be adjusted for the local market. Individual base pay is determined by role, level, location, skills, experience, and education. This position’s total rewards package includes competitive cash compensation, equity awards, benefits, and opportunities for professional development.
Base Pay Salary Range: $204,000 — $255,000 USD
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.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination.
#J-18808-Ljbffr