Senior Director, Qualified Person for Pharmacovigilance, Europe

The Opportunity:

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). The EU-QPPV has the authority to escalate safety concerns and to recommend urgent regulatory actions. 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. 

The key responsibilities of this role include 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, and acting as the primary point of contact for applicable authorities on a 24-hour basis.

The successful candidate will have innate leadership and organization skills, technical expertise in the field, and prior experience as an EU-QPPV. The EU-QPPV will be registered with the EMA, listed in the PSMF as the contact, and expected to join the GPS management team. 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 and to safeguard patient well-being.

Additional responsibilities include:

• PV System Oversight:

  • 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;

• Regulatory Compliance & EU QPPV Duties (as per GVP):

  • Act as the legally designated QPPV for the MAH in the EU and other regions as applicable;

  • Ensure compliance with EU PV legislation (Regulation (EC) No. 726/2004; Directive 2001/83/EC; Commission Implementing Regulation (EU) No 520/2012; EMA GVP Modules) and applicable national requirements.

• Together with GPS leadership, establish and maintain the MAH’s global PV System and promote, maintain, and improve compliance with applicable legal PV requirements.

• Ensure that the MAH’s PSMF is an accurate and up-to-date reflection of the MAH’s PV system.

• Ensure appropriate inspection readiness and manage regulatory inspections related to PV.

• Acts as the main interviewee during GVP inspections and manages CAPA process to resolve any deficiencies.

• For authorized medicinal products (or products currently undergoing authorization):

  • Maintain oversight of the product safety profiles and any emerging or significant safety issues;

  • Maintain awareness of conditions or obligations of the marketing authorizations and other commitments relating to safety or the safe use of the products;

  • Maintain awareness and authority over risk management plans, risk minimization measures and post-authorization safety studies;

  • Ensure conduct of PV activities and submission of all PV-related documents in accordance with legal requirements and GVP;

  • Ensure the necessary quality, including the correctness and completeness, of all PV data submitted to authorities;

  • Ensure a full and prompt response to any request from authorities for the provision of information necessary for the benefit-risk evaluation of a medicinal product and the provision of any other information relevant to the benefit-risk evaluation;

  • Provide input into the preparation of regulatory action in response to emerging or significant safety issues (e.g., safety variations, urgent safety restrictions, and communications to patients and healthcare professionals, recalls).

  • Ensure timely submissions of PSURs, Post-Authorisation Safety Studies (PASS), and emerging safety notifications.

  • Review and approve Risk Management Plan (RMP) and ensure that risk minimization measures (e.g. educational materials, if applicable) are effectively implemented.

• Act as the single PV contact point for applicable authorities on a 24-hour basis and as the contact point for PV inspections. Nominate and oversee a qualified deputy QPPV and maintain documented back-up procedures.

• Oversee the functioning of the PV system in all relevant aspects, including its quality system (e.g. procedures, contractual arrangements, database operations, quality, completeness and timeliness of expedited reporting and submission of periodic safety update reports, audits and PV training).

• Awareness of the validation status of IT systems used as part of the PV system, including any failures that occurred during validation and the corrective actions that have been taken to address the failures and significant changes that could have an impact on PV activities.

• Oversee the quality system, including relevant SOPs, staff training and compliance metrics for ICSR and aggregate report submissions.

• Delegate and document the delegation of specific tasks under supervision, to appropriately qualified and trained individuals, but maintain system oversight and overview of the safety profiles of all products.

• Leadership & Collaboration:

  • Act as a member of the GPS Leadership Team;

  • Lead cross-functional risk/crisis management committees as applicable;

  • Coordinate PV activities across affiliates, partners, and vendors to ensure consistency and compliance;

  • Inform and support tactical PV audit planning, support PV audits and PV inspections;

  • Provide PV guidance to internal teams and external partners;

  • Support due diligence and PV integration for business development activities;

  • Represent GPS in interdepartmental meetings, projects and working groups;

  • Represent the MAH in the European and International PV community (at conferences, working groups, and industry association meetings);

  • Lead, mentor, and manage Local Safety Responsible (LSR) personnel and support staff as applicable with budgeting authority.

Required Skills, Experience and Education:

• 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.

Preferred Skills:

• 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.

• Excellent influence and collaboration/teamwork capabilities.

• Strong organizational and time management skills, with the ability to prioritize and manage multiple tasks effectively.

Travel: Up to 20%.

Location & registration: The QPPV must be located within the EU/EEA. The MAH will register the appointed QPPV with the PSMF and competent authorities as required. The QPPV must be registered as the MAH’s Eudravigilance contact person. The QPPV is the primary contact for safety queries related to EV submissions.

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