Process ADR intake and PV cases with Claude AI and Google Sheets

Description

This workflow automates end-to-end pharmacovigilance (PV) case processing. It ingests ADR reports from web forms or emails, extracts and classifies events using Claude AI against MedDRA terminology, enriches with historical signal data, persists to a PV database, and triggers expedited regulatory alerts for serious/unexpected events.

How it works

Ingest ADR Report - Webhook receives ADR submission from patient/HCP portal or email parser
Validate & Normalize - Checks ICH E2B(R3) required fields, assigns case ID, classifies reporter
Wait — Deduplication Window - 10-minute hold to catch duplicate submissions from the same reporter
Claude AI Medical Coding - Extracts MedDRA PTs, classifies seriousness, causality, and expectedness
Signal Detection Enrichment - Queries historical PV database for disproportionality signals (PRR/ROR)
Wait — Regulatory Clock - Holds until expedited report window (7-day/15-day) deadline check
Persist PV Case Record - Writes structured E2B-compliant case to Google Sheets PV database
Expedited Alert & Reporting - Notifies PV team, triggers regulatory submission for serious/unexpected cases
Audit & Compliance Log - Full chain of custody for EMA/FDA inspection readiness

Setup Steps

Import workflow into n8n
Configure credentials:
Anthropic API - Claude AI for medical coding and causality assessment
Google Sheets - PV case database and audit log
SMTP / Gmail - Alerts to PV team and regulatory affairs
Set your product name, MAH name, and regulatory contact email
Configure signal detection thresholds (PRR, ROR) in enrichment node
Activate workflow

Sample ADR Payload
{
"productName": "DrugX 50mg",
"reporterType": "physician",
"reporterEmail": "[email protected]",
"patientAge": 54,
"patientSex": "female",
"adverseEvent": "severe chest pain and shortness of breath",
"eventOnsetDate": "2025-02-20",
"drugStartDate": "2025-01-10",
"doseStrength": "50mg",
"dosageFrequency": "once daily",
"outcome": "hospitalized",
"dechallenge": true,
"rechallenge": false
}

Regulatory Framework
ICH E2B(R3)** — Electronic transmission of ICSRs
ICH E2A** — Expedited reporting (7-day fatal/life-threatening, 15-day serious unexpected)
FDA 21 CFR 314.81** — NDA post-marketing reporting
EMA GVP Module VI** — Management and reporting of adverse reactions

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