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You will be responsible for providing medical safety expertise for the benefit/risk assessment of products in clinical development, with a specific focus on our key biologic (Nemolizumab). This involves signal detection, risk management
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
A strategic role that drives enhanced compliance throughout the PV domain to support the obligation of the Marketing Authorization Holders and appointed QPPV, to maintain and improve a Global PV system in accordance with international regulations. He/She
Provide expert advice on GVP compliance and regulatory matters, acting as quality partner to PV Operations (US/DK) and the EU QPPV. Author and maintain GVP Quality procedures and support implementation of new or updated GVP requirements.