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Manages the process to verify, through risk-based independent audit, compliance of PV activities with national/international regulations and guidelines on Good Pharmacovigilance...
Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product...
Develop and maintain excellent thought leader relationships in the field of rare disease specifically Fabry Disease, Pompe Disease and Batten Disease; Lead on medical initiatives...
Activities include but are not limited to, quality control of PV tasks fulfilled by DSE (EU headquarter office), EU affiliates, CROs and license partners and proactively monitors...
Provides direction and guidance to the PV Case Management function to ensure streamlined and efficient process, and fulfillment of support needed from other PV functions as well as...