Safety & Pharmacovigilance

Safety organizations face a structural challenge: case volumes are growing 8-12% annually, regulatory timelines are compressing, and qualified PV professionals remain scarce.

Key Shifts

Manual, repetitive processing → AI-assisted throughputPoint-in-time signal review → Continuous safety intelligenceReactive compliance → Predictive workload and risk management

Regulatory Context

Regulatory Context

Key regulations, frameworks, and standards that govern this domain.

Use Cases

Explore AI-powered use cases transforming safety & pharmacovigilance operations.

Use Cases

Explore how AI agents transform key processes across maturity levels.

Automated Case Intake

AI extracts AE data from structured and unstructured sources.

Faster case intake, reduced manual data entry.

AI-Assisted Narrative Generation

AI supports triage, routing, and narrative preparation.

Reduced processing time, improved throughput.

Signal Detection Enhancement

AI augments traditional methods with pattern recognition.

Earlier detection of safety signals.

Expedited Reporting Intelligence

AI tracks timelines, readiness, documentation.

Fewer late submissions, improved compliance.

Third-Party & Partner PV Oversight

AI monitors partner compliance, case reconciliation.

Reduced oversight effort, improved accountability.

Deep Dive

AI-Assisted Case Processing & Narrative Generation

The target end state is an AI-assisted, medically governed case processing capability that increases throughput while preserving human judgment.

Data Inputs

  • Safety database (ICSR records, metadata, status)
  • Source documents: CIOMS forms, literature, emails, transcripts
  • Controlled vocabularies: MedDRA, WHO-DD
  • Reporting rules: country-specific timelines and criteria
  • Historical cases: prior narratives, decisions, outcomes
  • Partner data: inbound cases from CROs or affiliates

Governance

  • Case processors review and refine AI-generated content
  • Medical reviewers approve seriousness, causality, narratives
  • AI suggestions are transparent and editable
  • All edits, approvals, decisions logged for inspection
  • Hallucination mitigation: source-grounded generation
  • Prompt governance: controlled templates, prohibited content
Measurable Impact

Expected Outcomes

Quantified improvements organizations can expect when deploying AI agents in this domain.

0

reduction in narrative drafting time

0

improved case throughput without added headcount

0

enhanced consistency across case narratives

0

reduction in late expedited submissions

Human-in-the-Loop Governance

Every AI agent operates under strict governance controls with human oversight at critical decision points.

Human-in-the-Loop

Governance Gates

Every AI action passes through defined governance checkpoints. Humans remain the ultimate decision-makers at every critical juncture.

AI Agent
Analyzes & Proposes
Governance
Review Gate
Human Expert
Reviews & Decides
G01

Case processors review and refine AI-generated content

G02

Medical reviewers approve seriousness, causality, narratives

G03

AI suggestions are transparent and editable

G04

All edits, approvals, decisions logged for inspection

G05

Hallucination mitigation: source-grounded generation

G06

Prompt governance: controlled templates, prohibited content

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See how AI agents can transform your safety & pharmacovigilance workflows with purpose-built automation and intelligent oversight.

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