Associate Director, Global Patient Safety Quality and Compliance - Pharmacovigilance at Revolut

Overview

Associate Director, Global Patient Safety Quality and Compliance - Pharmacovigilance role at Revolution Medicines. Redwood City, CA. Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The RAS(ON) Inhibitors aim to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors are intended for use in combination treatment strategies.

As a new member of the Revolution Medicines team, you will join other Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The AD GPS Quality and Compliance is responsible for the 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 Rev Med pharmaceutical products by driving compliance with global pharmacovigilance regulations and fostering a culture of safety and vigilance. Responsibilities include oversight of the PV-QMS, PV training, PV controlled documentation, inspection and audit management, ensuring inspection readiness, CAPA management, QA, and maintenance of GCP and GVP in partnership with GPS management, QA, and staff.

The AD of GPS Quality and Compliance will help to develop and implement the pharmacovigilance system in support of Revolution Medicines' research and development and marketed products. 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 support GCP/ICH quality leadership, strategic development of quality initiatives, and a culture focused on quality in the execution of the PV-QMS.

This role requires strategic thinking, expert knowledge of global PV regulations (GCP, GVP), effective communication, results orientation, collaboration with cross-functional teams, technical expertise, and vendor management skills to ensure regulatory compliance and patient safety.

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 high-quality, consistent performance;
• Coach GPS staff to ensure high-quality compliance support following best practices, global regulations, and internal requirements;
• Support management of 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 (Clinical Operations, Clinical Development, Clinical Data Science, Regulatory Affairs, Quality Assurance, Medical Affairs, and other departments) 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;
• Support GPS management in 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 (FDA, EMA, PMDA, ICH, and other relevant regulatory bodies);
• Support the GPS response to regulatory inquiries and inspections related to pharmacovigilance inspections;
• Support the development and maintenance of a pharmacovigilance quality system in line with global regulations (GCP, GVP) enabling demonstration of quality, effectiveness, and control;
• Partner…