Validation, Metrics and Documentation

The role of Validation, Metrics, and Documentation is a centralized role that: • Compiles and completes appropriate validation testing (writes test scripts and manages UAT (User Acceptance Testing) and appropriate documentation for ongoing support of production systems, the development of new or existing systems as well as the documented evidence that queries and reports have been independently verified and validated according to internal standards; • Performs, verifies, and documents the final testing and validation for production systems, new systems, tools and standard/ad hoc queries derived from the Argus safety database and/or other tools/applications supported by Customer Global Pharmacovigilance Department prior to release for use; • Ensures that the necessary documentation to support internal methodology using PUMA process (Project Unified Methodology Approach) in line with regulatory standards; • Validates ad hoc queries/report outputs from the safety database and/or related tools interfaced with the safety database; • Manages the validation activities performed by contractors and/or vendor to ensure accuracy and quality, ensuring that all validation work is completed according to project timelines; • Complies the SSDM (Systems Support & Data Management Team) quality and performance metrics as defined, tracked, and reported as part of the SSDM continuous improvement initiative; • Is the SME for internal /partner audits and inspections+ plus Project Management

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