Director, Patient Safety Intake and Regulatory Submissions  

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Description

This position is responsible for the oversight of the processes and systems which enable initial Intake of adverse event data (i.e., via electronic database capture (EDC), phone line, etc.), the subsequent reporting of Individual Case Safety Reports (ICSRs) to health authorities, Alliance Partners and internal destinations in compliance with applicable global regulations (ICH-GCP) and contractual obligations, and follow up activities to ensure receipt complete and accurate safety information. […]
This includes, but is not limited to expert knowledge of tools and systems that allow for data automation...

29 days ago from: irishjobs.ie

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