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The role is accountable for proactive safety surveillance, signal management, benefit–risk evaluation, and risk mitigation activities, in close partnership with Drug Safety & Pharmacovigilance internal team and cross-functional stakeholders
Takes responsibility for oversight and monitoring of the system for collection, processing, reconciliation and reporting of ICSRs for the DSE region. This includes ensuring ICSR report intake, case processing, workflow monitoring, follow-up requests,
In the absence of the QPPV and, as delegated, to take on the role and responsibilities of the QPPV, incl. acting as a single PV contact point for the competent authorities in the EEA and the UK on a 24‑hour basis; Support the QPPV in the compliant