职位描述

Deputy EU QPPV (m/f/d) – Senior Director, Patient Safety

Help shape how we protect patients across the EEA. In this highly visible leadership role, you will partner closely with the EU QPPV and the broader Patient Safety organization to ensure our pharmacovigilance system remains robust, inspection-ready, and responsive to emerging safety needs—so patients can benefit from our medicines with confidence.

Role at a glance

As Deputy EU QPPV, you act as the designated back-up for the EU QPPV during periods of absence and provide day-to-day operational leadership within the EU QPPV Office. You will influence key safety decisions, guide cross-functional partners, and represent the EU QPPV Office in governance forums—bringing clarity, rigor, and a strong patient-first mindset.

What you will do

• Serve as Deputy EU QPPV in line with EU legislation, applicable EU regulations/directives, and GVP Modules; act as back-up to the EU QPPV as required.

• Support critical PV oversight and approvals, including aggregate reports, Risk Management Plans, risk minimisation measures/materials, PASS, responses to regulatory authorities, and the Pharmacovigilance System Master File.

• Represent the EU QPPV Office in key internal governance forums (e.g., signal detection and product safety committees) and contribute to core safety information.

• Partner across Patient Safety to drive compliance for post-marketing and clinical trial safety activities and uphold company policies and standards.

• Provide expert advice to corporate functions on drug safety requirements and best practices.

• Strengthen PV system performance through oversight of vendor/partner/distributor collaborations and support for implementation of EU GVP Modules and relevant guidance.

• Lead and coordinate responses to emerging safety issues in the EEA, including support for safety-related regulatory procedures and interaction with health authorities as needed.

• Support ATMP/cell therapy risk management needs (where applicable), including additional risk minimisation measures and registry-related work, and representation in external stakeholder discussions.

• Operate with high autonomy: set priorities, manage operational aspects of the EU QPPV Office, and provide matrix leadership to drive outcomes.

What you bring

• Advanced medico-scientific degree with significant experience leading or co-leading complex, cross-functional work in life sciences.

• Demonstrated ability to provide strategic planning, governance, and oversight across multiple large-scale, complex assignments.

• Deep understanding of EU pharmacovigilance expectations (EU legislation, EU regulations/directives, and GVP Modules) and the ability to translate requirements into pragmatic, high-quality execution.

• Strong communication and stakeholder-management skills, with confidence to represent the EU QPPV Office in internal governance and, when required, with external authorities.

• Ability to work independently, set direction, and lead through influence in a matrix environment.

• Preferred: MD with extensive PV/drug safety experience in the EU biopharma industry.

Why this role matters

This is an opportunity to make a measurable impact on patient safety at scale—helping teams navigate complex benefit–risk decisions, strengthening oversight of our pharmacovigilance system, and ensuring we meet (and exceed) expectations from regulators and stakeholders across the EEA.

Works independently with minimal input, establishes work priorities and direction, manages operational aspects of the QPPV Office, and provides matrix leadership.