Principal Scientist, Global Patient Safety Surveillance

Revolution Medicines•Redwood City, CA

3d•$211,000 - $264,000•Hybrid

About The Position

The Principal Scientist of Safety Surveillance is a member of the Surveillance team and serves as a lead principal subject matter expert for the design, development, maintenance, and support of core Global Patient Safety (GPS) processes. The role leads and contributes to safety development activities and scientific innovation across areas such as safety risk management, signal detection and management, comparative benefit-risk, and aggregate reporting. The position supports effective scientific safety and pharmacovigilance activities in line with health authority and internal stakeholder requirements, anticipating developments in the operating environment and implementing improvements to maintain and refine processes. The role manages assigned safety processes and delivers required outputs in compliance with global regulatory requirements and best practices. It provides expert consultation to development and filing teams on pharmacovigilance content in regulatory reports and clinical study documents, and works with the EU Qualified Person Responsible for Pharmacovigilance to support European compliance as applicable. The Principal Scientist contributes to the PV quality system, inspection readiness, controlled documentation, and audit and inspection activities. The Principal Scientist also advances safety capabilities through strategic proposals, tailored solutions, process improvement, and innovation. The role partners with cross-functional stakeholders, internal policy governance bodies, development partners, and PV systems personnel; monitors regulatory and legislative developments; promotes consistent, high-quality safety surveillance across the portfolio; and communicates safety information effectively to internal and external stakeholders.

Requirements

Advanced degree in Medicine, Pharmacy, or a related field, such as MD, PharmD, PhD/MSc, or another postgraduate health professional qualification.
Minimum 10 years of experience in pharmacovigilance or a related field within the pharmaceutical or biotechnology industry.
Proven track record of leadership in pharmacovigilance.
In-depth knowledge of global pharmacovigilance regulations and guidelines, including ICH and GxP, and a record of compliance with these standards.
Strong analytical and strategic thinking, problem-solving, and decision-making skills.
Excellent communication, collaboration, and team management abilities, including the ability to influence senior executives and represent the company externally.
Technical expertise in pharmacovigilance.
Outstanding emotional intelligence.

Nice To Haves

Experience with advanced safety data analytics and pharmacovigilance systems.
Demonstrated ability to manage complex projects and work effectively in a matrixed organization.
Proficiency in managing regulatory interactions.
Strong organizational and time-management skills, with the ability to prioritize and manage multiple tasks effectively.
Excellent influence, collaboration, and teamwork capabilities.
BLA/MAA experience.

Responsibilities

Serve as lead principal subject matter expert for the design, development, maintenance, and support of one or more core Global Patient Safety processes, including comparative benefit-risk, signal detection and management, risk management, and aggregate reporting.
Manage assigned core safety processes and support delivery of outputs such as Risk Management Plans, Developmental Safety Update Reports, and Periodic Safety Update Reports in compliance with global regulatory requirements and best practices.
Provide expert consultation and direction to development and filing teams on pharmacovigilance portions of regulatory reports and clinical study documents, including protocols, informed consent forms, investigator brochures, NDA filing packages, safety narratives, and labeling strategy.
Lead development of controlled documentation to demonstrate oversight and control of the PV aggregate reporting process and other processes as needed.
Work with the EU Qualified Person Responsible for Pharmacovigilance to ensure European compliance as applicable.
Contribute to the development and maintenance of a pharmacovigilance quality system aligned with global regulations.
Ensure inspection readiness for global inspections by ensuring processes and training reflect applicable global regulatory requirements.
Act as subject matter expert for audits and inspections related to assigned processes.
Drive development of controlled documentation for GPS-owned processes and ensure Safety is represented in cross-functional settings.
Develop proposals to strategically influence, implement, improve, and innovate safety capabilities in line with GPS mission, vision, goals, and long-term strategy.
Create and implement tailored solutions that help GPS stakeholders deliver high-quality safety outputs amid emerging healthcare practice challenges and a changing regulatory landscape.
Partner closely with cross-functional stakeholders and anticipate strategic requirements for assigned processes.
Maintain expert knowledge of regulatory and legislative changes and healthcare-setting trends, anticipate future requirements, and apply best practices in assigned subject matter areas.
Translate and expand safety approaches across the portfolio to support consistent, high-quality safety surveillance.
Identify, share, and promote good-practice innovation and continuous process improvement.
Build collaborative relationships and partnerships for GPS and its internal and external cross-functional partners, including development partners.
Collaborate with internal policy governance bodies to adapt core processes to business needs and external requirements.
Ensure clear and effective communication of safety information to internal and external stakeholders.
Partner with PV systems personnel on development and implementation of fit-for-purpose PV systems.