Pharmacovigilance Safety Database and Case Management System

The buyer requires a pharmacovigilance safety database and case management system. The system must offer comprehensive case data management, including unique identifiers, versioning, record linking, and duplicate management with audit trails. It should support automation for efficiency in case intake, coding, and quality checks, and incorporate AI/NLP features with human oversight. The solution must enable data quality reporting on various issues and allow authorized users to design, save, rerun, and export reports using regulator-approved fields and filters. Eligibility is restricted to onshore Irish organizations. Proposals are sought for this offsite work.