Director, Global Patient Safety Surveillance

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 promote good practice innovation to enable continuous process improvement.

• Build relationships and collaborative partnerships for GPS and its cross-functional partners both internally and externally (i.e. with development partners).

• Collaboration and close interface with internal policy governance bodies in adapting core processes in line with business needs and external requirements.

• 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.

Required Skills, Experience and Education:

• 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, enabling exertion of strong and successful influence of senior executives as well as strong external representation for the company.

• Technical expertise in PV.

• Outstanding emotional intelligence.

Preferred Skills:

• Experience with advanced safety data analytics and PV 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 and collaboration/teamwork capabilities.

• BLA/MAA experience.

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