[Hiring] Senior Director, Qualified Person for Pharmacovigilance @Revolution Medicines

Role Description

We are seeking a highly qualified and experienced EU-QPPV to join our dynamic team. The EU-QPPV will report to the Head of Global Patient Safety (GPS) and is responsible for ensuring compliance with pharmacovigilance (PV) obligations under EU regulations and according to Good Pharmacovigilance Practices (GVP). The EU-QPPV maintains oversight of the Marketing Authorization Holder’s (MAH) global PV system and the safety profiles of the medicinal products covered by the PV system and is legally accountable for the establishment, maintenance, and oversight of the MAH PV system. The EU-QPPV acts as the primary point of contact for European Medicines Agency (EMA) and National Competent Authorities (NCAs). This role combines strategic leadership with operational accountability to safeguard patient safety and ensure regulatory compliance worldwide.

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.

Key Responsibilities

• Oversight of PV system and Quality Management System (QMS)
• Accountability for regulatory compliance and GVP
• Establishment and maintenance of the Pharmacovigilance System Master File (PSMF)
• Establishment of inspection readiness
• Compliance with applicable regulations regarding authorized medicinal products
• Acting as the primary point of contact for applicable authorities on a 24-hour basis

Additional Responsibilities

• Establish, maintain, and continuously improve the Pharmacovigilance (PV) System
• Ensure that the PV System is both appropriate and effective
• Ensure that all safety information is collected, processed and reported in compliance with EU regulations
• Oversee implementation of GVP requirements across the Revolution Medicines organization
• Maintain oversight of PV activities performed by affiliates, vendors, and partners
• Act as the legally designated QPPV for the MAH in the EU and other regions as applicable
• Ensure compliance with EU PV legislation and applicable national requirements
• Maintain oversight of the product safety profiles and any emerging or significant safety issues
• Ensure timely submissions of PSURs, Post-Authorisation Safety Studies (PASS), and emerging safety notifications
• Act as the single PV contact point for applicable authorities on a 24-hour basis
• Oversee the functioning of the PV system in all relevant aspects
• Delegate and document the delegation of specific tasks under supervision

Qualifications

• Advanced degree in Life Sciences, Pharmacy, Medicine, or related field; Medical degree strongly preferred
• 12+ years of experience in pharmacovigilance, with at least 5 years in a QPPV or senior PV leadership role
• In-depth knowledge of GVP, EU PV legislation and global regulatory frameworks
• Proven experience managing global PV systems and interacting with health authorities
• Excellent understanding of drug development and life-cycle management of medicinal products
• Fluent in written and spoken English; fluency in a second European language an advantage

Requirements

• Regulatory expertise and strategic thinking
• Strong leadership, communication, and organizational skills
• Track record of leading and building a high performing team
• Ability to manage complex global PV operations
• Excellent stakeholder management and decision-making skills
• Strong organizational and time management skills, with the ability to prioritize and manage multiple tasks effectively

Benefits

• Remote work options
• Comprehensive health benefits
• Professional development opportunities
• Collaborative work environment

Company Description

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.