Senior 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 Senior Director of Safety Surveillance is a senior member of the Surveillance team serving as a line leader of their team and subject matter expert for the design, development, maintenance, and support of core Global Patient Safety (GPS) processes. This individual will oversee and/or lead 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 Senior Director of Safety Surveillance serves in a critical enabling and strategic position, ensuring that Revolution Medicines continuously delivers effective scientific safety activities and/or pharmacovigilance (PV) activities, in line with health authority and internal stakeholder requirements. The Senior Director of Safety Surveillance will have an extensive understanding of all aspects 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:

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Establish and provide effective leadership, mentorship, and accountability for an experienced global team and for the quality of their work in building and maintaining safety processes and other safety development activities according to the values of Revolution Medicines.

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Management of team resources under their responsibility are deployed according to the priorities of GPS and for the improvement of PV system quality.

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Provide relevant subject matter expertise 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.

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Provide strategic direction and leadership where necessary to the GPS team and cross-functional Development staff to manage the core safety processes 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.

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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.

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Lead and/or oversee the development of controlled documentation required to demonstrate control and oversight of the PV aggregate reporting process and other processes as needed.

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Work with the EU Qualified Person Responsible for Pharmacovigilance (QPPV) to ensure European compliance as applicable.

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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.

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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 where required.

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

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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.

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Create and implement bespoke solutions that enable GPS stakeholders to provide high-quality safety outputs that address emerging challenges in the h

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