Pharmacovigilance
AE capture, signal detection, and case management automation for global pharmacovigilance operations.
The problem
A global pharmacovigilance operation needed to capture adverse events from multiple sources, detect signals, and manage cases — with audit-grade evidence and regulatory readiness.
How we engineered it
- 1Built AE capture across email, voice, and digital channels with document AI for unstructured input
- 2Implemented signal-detection workflows aligned to FDA and EMA expectations
- 3Engineered the case-management workflow with reviewer queues and SLA monitoring
- 4Provided audit-ready evidence for every case state transition
What shipped
Measured outcomes from the program — not promises.
What we built it on
Access the complete case study — including detailed timelines, architecture decisions, and measurable outcomes.
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