💊 AI autopilot · pharma

Pharmacovigilance autopilot

Processes adverse-event cases — a QPPV / drug-safety physician signs before reporting.

Drug-safety / PV leadbuys it $1.65B outsourcedmarket 5 auto · 1 humanflow steps

The problem

Pharmacovigilance is high-volume ICSR processing under a 15-day expedited clock, where a named QPPV is legally accountable for every causality and seriousness call.

What you get

Cases coded, de-duplicated and causality-assessed straight-through; the QPPV signs before any safety report is submitted.

The flow

Intake to outcome. 🤖 steps run automatically; 🧑‍⚖️ steps are where a named human signs off the judgment calls.

  1. 1
    🤖 Intake the adverse-event case (ICSR) from the source
    agent intake · ICSR / case intakeEHR (FHIR)
  2. 2
    🤖 MedDRA-code the terms, de-duplicate, and triage seriousness / expectedness
    agent coder · MedDRA coding
  3. 3
    🤖 Assess causality and check the 15-day expedited-reporting clock
    agent compliance · Causality assessment
  4. 4
    🧑‍⚖️ The QPPV / drug-safety physician signs the case assessment Human checkpoint
    QPPV / drug-safety physician
  5. 5
    🤖 Submit the safety report (E2B) to FAERS / EudraVigilance ⚠ Irreversible · high blast
    agent submit · Safety report (E2B / FAERS)
  6. 6
    🤖 Run signal detection and maintain the safety database
    agent monitor · ICSR / case intake

Agents & tools

  • ICSR / case intake stub → Argus
  • EHR (FHIR) ● live · Epic
  • MedDRA coding ● live · MedDRA
  • Causality assessment stub → WHO-UMC
  • Safety report (E2B / FAERS) ● live · FDA FAERS

3 of these run live on real data — keyless by default; the rest are sandbox stubs that flip to the real provider the moment you add credentials.

Human checkpoints

  • QPPV / drug-safety physician — The QPPV / drug-safety physician signs the case assessment

The autopilot escalates the judgment calls to a qualified human — the rest is straight-through.

Why it's safe to let it run

Every autonomous decision is logged — who · what · confidence. Signed human checkpoints and a built-in compliance reviewer enforce the rails, so the outcome holds up to an audit, not just a demo. Every irreversible action runs only after a human signs — the autopilot does the volume, never the point of no return on its own.

🧑 Accountable owner: QPPV / drug-safety physician — one person answers for what this autopilot does.

Related autopilots

Same buyer, adjacent function — the connectors and compliance packs are shared.

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