An enterprise AI assistant that reads adverse-event reports in plain language, drafts a coded and enriched pharmacovigilance case, and submits it for medical review — inside Microsoft Teams. Specialists stay in control of every decision; every action is logged, hashed, and inspection-ready.
When AI absorbs the manual work of case intake and coding, specialists are freed for clinical judgement — and every case and AI decision is measured on a live dashboard, so the value is visible and accountable.
Intake, coding and enrichment that took hours are drafted in minutes.
The AI extracts and pre-fills case details, so specialists stop retyping reports.
Standardized MedDRA & WHODrug suggestions reduce variation between reviewers.
Every action and AI decision captured, hashed and ready for inspection.
Measured, not assumed. Case throughput, time saved, coding accuracy and audit completeness are tracked in a live Power BI dashboard, while every AI decision is monitored in Application Insights — giving leadership a clear, auditable view of ROI and compliance.
Teams describe the event in plain language. The assistant does the heavy lifting and hands a clean, coded draft back for review.
Extracts the adverse events, suspect drugs, patient details and dates from an unstructured report — no forms to fill in.
Suggests the right MedDRA term for each reaction and the WHODrug entry for each product, ready for the reviewer to confirm.
Pulls in drug-safety context and flags potential drug–drug interactions, so important signals surface early.
Creates, queries, updates, summarizes and deactivates cases across their full lifecycle — never deleting anything.
The assistant prepares the work; a qualified reviewer approves it. Nothing is written to the safety record until a person signs off.
Same login, same security, no new application to learn — and your data stays inside your own Microsoft cloud tenant. Built entirely on enterprise tools you already own and trust.
It's a hybrid build. A low-code Copilot Studio agent gives the safety team a natural conversation in Teams and runs the human-approval step; it calls a pro-code FastAPI service on Azure that does the real work — reading text, proposing coding via the AI model, enriching, and enforcing the rules. The AI only ever suggests; all access control, writes, hashing and audit logging are deterministic and human-gated.
Designed for regulated pharmacovigilance, with the controls and oversight quality, compliance and inspection teams expect.
Every write runs behind a human-in-the-loop approval — a qualified reviewer signs off before anything is recorded.
Entra ID with role-based access — PV Officer, Medical Reviewer, Auditor and Admin each see and do only what their role allows.
An append-only log with SHA-256 before/after hashing — no record is ever hard-deleted, only deactivated or archived.
Every AI prompt, response and decision is captured in Application Insights and surfaced in Power BI.
No invented codes. The assistant proposes terms grounded in the actual MedDRA and WHODrug dictionaries — it selects the correct official term rather than guessing, so every suggestion is traceable and verifiable.
This is one of several real-world AI builds. See the full portfolio — and what could be built for your organization.
Visit lisekarimi.com →