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This position develops, implements, and oversees processes and procedures for clinical trial ICSR processing activities, including oversight of the case processing outsourced service provider(s). The incumbent will work in close collaboration with pharmacovigilance physicians and cross-functional team members on operational safety issues. This individual will ensure that vendors are following relevant safety management plans and providing high quality ICSRs, through collection and analysis of KPIs. This individual will ensure compliance and adherence to Alnylam pharmacovigilance processes and global regulatory requirements.