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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.
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.
Your key responsibilities will be to influence the performance of the quality system and the PV activities; to promote, maintain and improve compliance with the legal requirements; to maintain an overview of medicinal product safety profiles and any
Responsible for assisting with defining compound/program medical strategies and for leading select medical affairs projects within a specific compound or indication. Support GMA the development of the Global Medical Affairs strategy and execution of the
Ensuring that all the activities performed are maintained in compliance with applicable regulations, that appropriate authorizations/licenses and certificates are in place and current and that the integrity and safety of product are maintained throughout