VigiHelp is an AI pharmacovigilance database designed to capture verbatim, extract adverse events, support MedDRA coding, and create structured safety cases.
The platform combines case data management, AI-assisted causality assessment, quality control of existing case data and causality, and authority submission through ESG in one workflow for pharmacovigilance teams.
What VigiHelp brings to pharmacovigilance teams
Store and manage structured safety cases in one place instead of fragmented spreadsheets and files.
Extract adverse events from verbatim, code them in MedDRA, and create usable case records faster.
Generate causality assessment support and review existing case data and causality quality.
From source narrative to compliant pharmacovigilance output and authority submission
Collect source narratives and preserve the original wording for traceability.
Extract adverse events from the narrative and support reviewer-controlled MedDRA coding.
Use AI-assisted evidence review to support causality assessment and reduce repetitive manual review work.
Route finalized regulatory submissions through the Electronic Submissions Gateway as the last step in the workflow.