Principal Scientist, Global Patient Safety Surveillance

Revolution Medicines•Redwood City, CA

10h•$211,000 - $264,000•Hybrid

About The Position

The Principal Scientist of Safety Surveillance is a lead subject matter expert on Revolution Medicines’ Global Patient Safety (GPS) Surveillance team. The role designs, develops, maintains, and supports core GPS processes and contributes to safety development activities and scientific innovation across clinical safety and pharmacovigilance disciplines, including safety risk management, signal detection and management, comparative benefit-risk, and aggregate reporting. The position helps ensure effective safety and pharmacovigilance activities meet health authority and internal stakeholder requirements, while anticipating changes in the operating environment and implementing process improvements. The role manages assigned safety processes and their required outputs, provides expert consultation to development and filing teams, and leads controlled documentation and quality-system activities. It works with the EU QPPV on European compliance, supports global inspection readiness, and serves as a subject matter expert during audits and inspections. The Principal Scientist partners with cross-functional teams and PV systems personnel, communicates safety information to internal and external stakeholders, and advances consistent, high-quality safety surveillance across the portfolio.

Requirements

Advanced degree in Medicine, Pharmacy, or a related field, such as MD, PharmD, PhD/MSc, or another postgraduate health professional qualification.
At least 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, including the ability to prioritize and manage multiple tasks.
Excellent influence, collaboration, and teamwork capabilities.
BLA/MAA experience.

Responsibilities

Serve as the lead principal subject matter expert for the design, development, maintenance, and support of one or more core Global Patient Safety processes, in compliance with applicable GCP, GVP, and GDocP requirements.
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 content in 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 demonstrating control and oversight 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 development and maintenance of a PV quality system aligned with global regulations, including GCP and GVP.
Ensure global inspection readiness by ensuring processes and training reflect applicable regulatory requirements; act as the subject matter expert for audits and inspections for assigned processes.
Drive development of controlled documentation for GPS-owned processes and ensure Safety’s perspective is represented in cross-functional settings.
Develop proposals that strategically influence, implement, improve, and innovate safety capabilities in line with GPS strategy.
Create and implement tailored solutions that enable GPS stakeholders to provide high-quality safety outputs amid emerging healthcare 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 trends, anticipating future requirements and applying best practices in assigned subject matter areas.
Translate and expand new and established 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 partnerships for GPS with 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 to develop and implement fit-for-purpose PV systems.