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. * Partner across Patient Safety to drive compliance for post-marketing and clinical trial safety activities and uphold company policies and standards. * Support ATMP/cell therapy risk management needs (where applicable), including additional risk minimisation measures and registry-related work, and representation in external stakeholder discussions. * 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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