Director, Global Patient Safety Surveillance

Job description

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.

The Opportunity:

The Principal Scientist of Safety Surveillance is a member of the Surveillance team serving as a lead principal subject matter expert for the design, development, maintenance, and support of core Global Patient Safety (GPS) processes. This individual will lead and/or contribute to safety development activities including scientific innovation and enablement across various disciplines relevant to clinical safety and pharmacovigilance, such as but not limited to safety risk management, signal detection & management, comparative benefit-risk, and aggregate reporting. The Principal Scientist of Safety Surveillance supports Revolution Medicines to continuously deliver effective scientific safety activities and/or pharmacovigilance (PV) activities, in line with health authority and internal stakeholder requirements. The Principal Scientist of Safety Surveillance will have robust and highly experienced understanding of the internal and external operating environment, which will enable anticipation of new developments and implementation of improvements critical to process maintenance and refinement at Revolution Medicines.

Responsibilities include:

•
Serve as the lead principal subject matter expert for the design, development, maintenance, and support of one or more core GPS processes (i.e. comparative benefit-risk, signal detection & management, risk management, aggregate reporting, etc.) in compliance with applicable Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Documentation Practices (GDocP), etc., in alignment with the company’s mission and objectives.

•
Manage the assigned core safety process(es) and support the execution/delivery of the required outputs (e.g. Risk Management Plans (RMPs), Developmental Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), etc.) in compliance with global regulatory requirements and following best practices.

•
Provide expert consultation and direction for Development and filing teams where impactful as it relates to PV portions of regulatory reports and clinical study documents (including Clinical Protocols, Informed Consent Forms, Investigator Brochures, NDA filing packages (i.e. Module 2: Clinical Overview, Clinical Summary, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), safety narratives), and labeling strategy.

•
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 as applicable.

•
Contribute to the development and maintenance of a PV quality system in line with global regulations (i.e. GCP, GVP) enabling demonstration of quality, effectiveness, and control.

•
Ensure inspection readiness for global inspections by ensuring processes and training reflect global regulatory requirements as applicable. Act as subject matter expert (SME) for audit and inspection for the assigned process(es).

•
Drive development of controlled documentation for GPS owned processes as applicable and ensure that Safety’s voice is heard in cross-functional settings.

•
Strategically influence, implement, improve, and innovate through the development of proposals that advance safety capabilities in line with the GPS mission, vision, goals, and long-term strategy.

•
Create and implement bespoke solutions that enable GPS stakeholders to provide high-quality safety outputs that address emerging challenges in the healthcare practice setting against a dynamic regulatory landscape.

•
Work in close partnership with cross-functional stakeholders and anticipate strategic requirements with respect to the assigned process(es).

•
Maintain expert knowledge of key regulatory/legislative changes and trends in the evolving healthcare setting to anticipate future requirements and apply best practices in the assigned SME area(s).

•
Translate/expand new and established safety approaches across the RevMed portfolio to enable consistent and high-quality safety surveillance.

•
Identify, share, and promo

Prepare for the interview

Nothing collected for this employer yet. The Blind 75 is what technical screens draw from; practise it here, with a coach, in Java or Python.

More at Revolution Medicines

• Executive Director, US Portfolio Analytics · Redwood City, California, United States
• Senior Research Associate, DMPK · Redwood City, California, United States
• Senior Administrative Assistant II, Commercialization · Redwood City, California, United States
• Director, Drug Product · Redwood City, California, United States
• Contract Administrator III · Redwood City, California, United States
• Senior Administration Assistant · Redwood City, California, United States
• Associate Director, Payroll, Europe · Basel, Switzerland
• Principal Product Manager, Chemistry · Redwood City, California, United States