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. * Support ATMP/cell therapy risk management needs (where applicable), including additional risk minimisation measures and registry-related work, and representation in external stakeholder discussions. Works independently with minimal input, establishes work priorities and direction, manages operational aspects of the QPPV Office, and provides matrix leadership. * Strong communication and stakeholder-management skills, with confidence to represent the EU QPPV Office in internal governance and, when required, with external authorities.
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