Associate Director, Deputy QPPV, Europe

Revolution Medicines

1d•Hybrid

About The Position

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. The Opportunity: We are seeking a highly qualified and experienced EU-dQPPV to join our dynamic team and will report to the QPPV. The Deputy EU Qualified Person for Pharmacovigilance (Deputy EU QPPV) serves as the designated deputy to the EU QPPV and supports the oversight, maintenance, and continuous improvement of the company's European pharmacovigilance (PV) system. The role ensures compliance with European Union pharmacovigilance legislation, Good Pharmacovigilance Practices (GVP), and applicable local requirements. The Associate Director, Deputy QPPV supports the QPPV in maintaining, executing, and continuously improving a fully compliant global Pharmacovigilance system. In the absence of the QPPV, this individual assumes full legal and functional responsibility for the safety of all marketed products and products under clinical development.

Requirements

Advanced degree in life sciences (MD, PharmD, PhD, or MSc in a relevant scientific discipline).
7–9+ years of experience in international pharmacovigilance, with a strong focus on PV quality, compliance, or QPPV office operations.
Experience managing global PV systems and interacting with health authorities.
Fluent in written and spoken English, fluency in a second European language an advantage.
In-depth knowledge of GVP, EU PV legislation and global regulatory frameworks.

Nice To Haves

Familiarity with PV systems, databases, and PSMF management.
Excellent communication and stakeholder management skills.
Strong analytical and problem-solving capabilities.
Ability to work effectively in a fast-paced biotechnology environment.

Responsibilities

Support the EU QPPV in maintaining and overseeing the Pharmacovigilance System Master File (PSMF).
Track key performance indicators (KPIs) and compliance metrics for case processing, aggregate reporting, and signal detection.
Review and approve Safety Data Exchange Agreements (SDEAs) with commercial partners and local affiliates.
Act as the delegated EU QPPV during periods of absence, ensuring uninterrupted oversight of the EU PV system.
Maintain continuous awareness of emerging safety issues, regulatory inspections, audits, and compliance obligations.
Support interactions with European Medicines Agency (EMA), national competent authorities, and other regulatory agencies.
Ensure adequate arrangements exist for 24/7 availability of the EU QPPV function.
Contribute to signal detection, signal management, safety evaluation, and benefit-risk assessment activities.
Review and provide strategic input into Risk Management Plans (RMPs), signal assessments, and safety governance discussions.
Support oversight of aggregate safety reports including PSURs/PBRERs and Development Safety Update Reports (DSURs), as applicable.
Support preparation and management of regulatory inspections and internal/external audits.
Track and oversee implementation of corrective and preventive actions (CAPAs).
Monitor key PV compliance metrics and ensure timely escalation of compliance risks.
Contribute to Safety Data Exchange Agreements (SDEAs) and pharmacovigilance contractual requirements.
Ensure responsibilities and compliance expectations are clearly defined and monitored.
Ensure local PV contacts (LCPs) and affiliates adhere to global data collection timelines and reconciliation standards.
Support and provide GVP and safety awareness training across the organization and to external vendors.