Executive Director, Global Patient Safety Quality and Compliance - Pharmacovigilance

About the role

We are seeking a skilled and experienced Executive Director (ED) of Global Patient Safety (GPS) Quality and Compliance to join our dynamic team. The ED GPS Quality and Compliance is responsible for the strategy, development, oversight, and execution of the pharmacovigilance quality management system (PV-QMS) within the organization. This role ensures the safety of patients and the overall positive benefit-risk of RevMed pharmaceutical products by driving compliance with global pharmacovigilance regulations and fostering a culture of safety and vigilance. The responsibilities of this role include oversight of the PV-QMS , PV training strategy, PV controlled documentation, inspection and audit management, ensuring inspection readiness, Corrective Action Preventive Action (CAPA) management, Quality Assurance (QA), and maintenance of Good Clinical Practice (GCP), and Good Pharmacovigilance Practices (GVP) in partnership with GPS management, QA, and staff. The ED of GPS Quality and Compliance will help to develop and implement the pharmacovigilance system in support of Revolution Medicine's research and development and marketed products. The successful candidate will have innate leadership and organization skills, technical expertise in the field, and experience in organizing and overseeing pharmacovigilance quality, compliance, and training. As an ED, you will work closely with the GPS management team to develop and build out the PV-QMS as an important component of a fully compliant pharmacovigilance system; you will be responsible for GCP/ICH quality leadership, strategic development of quality initiatives and support a quality focused culture in the execution of the PV-QMS. This critical role will require strategic thinking, expert knowledge of global PV regulations (i.e. GCP, GVP), the ability to influence and communicate ideas effectively, results orientation, collaboration with cross-functional teams, technical expertise, and vendor management skills to ensure compliance with regulatory requirements to safeguard patient well-being. Additional responsibilities include: In cooperation with the GPS leadership team, co-develop and implement the global pharmacovigilance quality management system strategy in alignment with the company's mission and objectives. Develop and implement a PV training strategy that ensures compliance and ensures high quality and consistent performance. Provide strategic direction and leadership to GPS and cross-functionally. Lead, mentor, and coach GPS staff ensuring high quality compliance support following best practices, global regulations, and internal requirements. Oversee the resourcing, budget, and management of pharmacovigilance contract research organizations (PV CROs) in quality and compliance activities. Author and contribute to the preparation of controlled documentation required by health authorities for management of the QMS. Develop and maintain relationships across Revolution Medicines, particularly in Clinical Operations, Clinical Development, Clinical Data Science, Regulatory Affairs, Quality Assurance, Medical Affairs, and other departments as appropriate to ensure a globally compliant QMS. Collaborate to create robust processes to maintain compliance with safety requirements related to safety science processes. Work with the EU Qualified Person Responsible for Pharmacovigilance (EU-QPPV) to ensure European compliance as applicable. Responsible for ensuring inspection readiness for global inspections by ensuring all processes and training reflect global regulatory requirements. Manage all inspections that include PV and ensure completion and tracking of CAPAs. Foster a culture of safety, compliance, and continuous improvement within the pharmacovigilance function and broadly across the organization. Ensure compliance with global pharmacovigilance regulations and standards, including FDA, EMA, PMDA, ICH, and other relevant regulatory bodies. Lead the GPS response to regulatory inquiries and inspections related to pharmacovigilance inspections. Lead the development and maintenance of a pharmacovigilance quality system in line with global regulations (i.e. GCP, GVP) enabling demonstration

Benefits

Additional Information

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

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