Pharmacovigilance AI for case intake reads incoming adverse event reports from mailboxes, scanned forms, partner files and literature, extracts reporter, patient, product and reaction details into structured fields, flags reports missing a validity criterion and lists possible duplicates. Case processors confirm every field, and qualified safety staff assess seriousness, expectedness and causality. The agent never submits ICSRs and never makes a medical judgement.
Trigger: A message, document or publication that may describe a suspected adverse reaction reaches a safety intake channel. Owner: Head of Pharmacovigilance Operations. Primary output: Pre-filled case draft with source citations for every field. Consequential actions require approval.
Assess your workflowCase volumes grow with every new market, partner and literature source, yet each report still needs careful reading, and the regulatory clock starts on the day any employee or contractor learns of a valid case.
VDF AI agents triage the intake queue, extract case details with citations to the source text, mask personal data where it is not needed and hand case processors a pre-filled draft with a validity checklist to verify.
Sorts incoming mail, scanned forms and partner files into potential adverse event reports, product complaints, medical enquiries and unrelated messages.
Pulls reporter, patient, product, reaction and timing details into structured fields and links each value to the sentence it came from.
Checks the four minimum criteria for a valid case and lists missing items so a processor can request follow-up.
Compares each new report with existing cases on patient descriptors, product, reaction and dates, and lists candidates for a person to confirm.
Detects personal identifiers and masks them in copies used for analytics, training material or literature summaries.
Each pharmacovigilance case intake source has a defined purpose, freshness expectation, quality gate, and sensitivity boundary.
Purpose: Give the agents every report that could start a submission clock.
Freshness: Polled continuously so day zero is never lost to an unread inbox.
Quality: Each item keeps its receipt timestamp, channel and original attachment.
Sensitivity: Treat all items as health data and limit access to the safety team.
Purpose: Identify publications that describe a suspected reaction to a company product.
Freshness: Run at least weekly, in line with the search strategy in your procedures.
Quality: Store the search string, database, date and article identifier with every hit.
Sensitivity: Respect publisher licence terms when storing or sharing full texts.
Purpose: Support duplicate checks and show processors related prior reports.
Freshness: Refreshed daily from the system of record.
Quality: Case identifiers and version numbers must match the safety database exactly.
Sensitivity: Export only the fields needed for duplicate detection.
Sample drafts weekly during the pilot and monthly after go-live, and repeat validation testing after any model or prompt change.
Intake is the part of drug safety where volume and deadlines collide. Under EMA’s GVP Module VI, a valid case needs an identifiable reporter, one identifiable patient, a suspected product and a suspected reaction. Serious cases go to EudraVigilance within 15 days and non-serious ones within 90, counted from day zero. In the US, 21 CFR 314.80 requires 15-day Alert reports for serious and unexpected experiences, review of information from any source including the scientific literature, and ten years of record retention.
The workflow suits teams with steady report volume, several intake channels and a quality system that can validate a new tool. It is a poor fit when report volume is tiny or when the expectation is that software will replace safety physicians.
| Intake step | Agent output | Human decision |
|---|---|---|
| Triage | Category with the deciding passage | Close or keep each item |
| Extraction | Cited field values | Accept or correct every field |
| Validity | Missing-criteria checklist | Validity and follow-up |
| Duplicates | Ranked candidate cases | Merge, link or keep separate |
For follow-up reports, a diff of the new and previous versions shows processors exactly what changed. On the submission side, the FDA electronic submissions page states that ICSRs sent through ESG NextGen must use E2B(R3) from 1 October 2026 (verified October 2026). That work stays in the safety database.
VDF AI Agents run on-premises, in a private cloud or air-gapped, so case documents stay in your environment. Agents can combine catalog tools for OCR, translation and table extraction with PII detection and PII redaction for copies that leave the case record.
VDF holds no GxP or regulatory certification of its own. It is software that runs under your quality system, so validation, access control and SOPs remain yours.
More healthcare workflows are in the healthcare use cases, including literature review support, regulatory knowledge chat for pharma and coding validation.
Control: Processors review every item the agent labels as not an adverse event before it is closed.
Accountable owner: Intake team lead
Control: Every field links to its source sentence, and processors confirm fields before data entry.
Accountable owner: Case processing lead
Control: Detect and mask identifiers outside the case record, and run agents only inside your environment.
Accountable owner: Data protection officer
Pilot on one market's spontaneous reports in parallel with normal processing, so every case is still entered and assessed by the existing team.
Assign these prebuilt tools to the bounded agents in Pharmacovigilance Case Intake, or browse all VDF AI tools.
These sources inform the governance and evaluation approach for Pharmacovigilance Case Intake. They do not certify a specific deployment.
Written by VDF AI Editorial Team. Last reviewed 6 October 2026.
Answers for Head of Pharmacovigilance Operations evaluating this workflow's data, controls, measures, and operating boundaries.
Talk to an expertIt should not. Seriousness, expectedness and causality are medical judgements that belong to qualified safety staff. The agent's job is to put the relevant facts in front of them quickly: the reaction as reported, onset timing, dechallenge information and any hospitalisation, each linked to the exact sentence in the source.
No. Submission stays in your validated safety database and its gateway connections. The agent prepares a draft that a processor verifies before data entry. That matters more now that FDA requires E2B(R3) for postmarketing ICSRs sent through ESG NextGen from 1 October 2026 (verified October 2026), because format errors are caught at the gateway, not by the agent.
EU guidance expects at least weekly searches of major reference databases, and the reporting clock for a literature case starts when the company becomes aware of a publication that meets the minimum criteria. An agent can screen new abstracts and full texts, flag articles that mention a company product with an identifiable patient and reaction, and queue them for a reviewer the same day.
Run the agents inside your own environment so source documents never reach a public model service. Keep the identifiers a valid case needs, such as initials or age, in the case draft, and mask names, addresses and contact details in every copy used for analytics, training or management reporting.
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