Sr Director, Patient Safety - Deputy EU-QPPV

Sr Director, Patient Safety - Deputy EU-QPPV

Gilead

Munich, Germany

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.