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About the Role
The Principal Scientist of Safety Surveillance is a lead principal subject matter expert for Global Patient Safety (GPS) processes, driving scientific innovation and enablement in clinical safety and pharmacovigilance. This role supports the continuous delivery of effective scientific safety and pharmacovigilance activities, anticipating new developments and implementing improvements critical to process maintenance and refinement.
Responsibilities
- Serve as the lead principal subject matter expert for the design, development, maintenance, and support of core GPS processes in compliance with applicable Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and Good Documentation Practices (GDocP).
- Manage assigned core safety process(es) and support the execution/delivery of required outputs such as Risk Management Plans (RMPs), Developmental Safety Update Reports (DSURs), and Periodic Safety Update Reports (PSURs) in compliance with global regulatory requirements.
- Provide expert consultation and direction for Development and filing teams regarding PV portions of regulatory reports and clinical study documents.
- Lead the development of controlled documentation required to demonstrate control and oversight of the PV aggregate reporting process and other processes as needed.
- Work with the EU Qualified Person Responsible for Pharmacovigilance (QPPV) to ensure European compliance.
- Contribute to the development and maintenance of a PV quality system in line with global regulations.
- Ensure inspection readiness for global inspections by ensuring processes and training reflect global regulatory requirements.
- Act as subject matter expert (SME) for audit and inspection for the assigned process(es).
- Drive development of controlled documentation for GPS owned processes and ensure Safety’s voice is heard in cross-functional settings.
- Strategically influence, implement, improve, and innovate through the development of proposals that advance safety capabilities.
- Create and implement bespoke solutions that enable GPS stakeholders to provide high-quality safety outputs.
- Work in close partnership with cross-functional stakeholders and anticipate strategic requirements.
- Maintain expert knowledge of key regulatory/legislative changes and trends in the evolving healthcare setting.
- Translate/expand new and established safety approaches across the RevMed portfolio.
- Identify, share, and promote good practice innovation.
- Build relationships and collaborative partnerships for GPS and its cross-functional partners.
- Collaborate with internal policy governance bodies in adapting core processes.
- Ensure clear and effective communication of safety information to internal and external stakeholders.
- Partner with PV systems personnel in the development and implementation of fit for purpose PV systems.
Requirements
- Advanced degree in Medicine, Pharmacy, or a related field (MD, PharmD, PhD/MSc, or other post-graduate health professional qualification).
- Minimum of 10 years of experience in PV or related field within the pharmaceutical or biotechnology industry.
- Proven track record of leadership in PV.
- In-depth knowledge of global PV regulations and guidelines (i.e. ICH, 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.
- Outstanding emotional intelligence.
Skills
- Technical expertise in PV
- Advanced safety data analytics
- PV systems
- Managing complex projects
- Working effectively in a matrixed organization
- Managing regulatory interactions
- Organizational skills
- Time management skills
- Prioritization skills
- Managing multiple tasks effectively
- Influence capabilities
- Collaboration capabilities
- Teamwork capabilities
- BLA/MAA experience
Location
- Hybrid
Work Type
- Hybrid
- Full-time
Experience Level
- Principal Scientist
- 10+ years of experience
Education Level
- Advanced degree in Medicine, Pharmacy, or a related field (MD, PharmD, PhD/MSc, or other post-graduate health professional qualification)
About the Company
- Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers.
- Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS.
- Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.
- Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients.
Equal Opportunity
- 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.
- We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines.
- These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message.
- Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process.
- All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.
- If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to careers@revmed.com so we can share these impersonations with our IT team for tracking and awareness.