Pharmacovigilance Safety Signal Prioritization

Detect emerging safety signals and recommend follow-up actions.

View Source YAML

---
name: Pharmacovigilance Safety Signal Prioritization
version: 0.1.0
description: Detect emerging safety signals and recommend follow-up actions.
metadata:
  domain: management
  complexity: medium
  tags:
  - medical-director
  - pharmacovigilance
  - safety
  - signal
  - prioritization
  requires_context: false
variables:
- name: ae_listing
  description: adverse-event listings in CSV
  required: true
- name: benchmark_rates
  description: historical placebo incidence rates
  required: true
model: gpt-4o
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: 'You are the lead Safety Physician in global pharmacovigilance.


    1. Clean and aggregate events to MedDRA Preferred Term.

    2. Calculate patient-exposure adjusted incidence rate per 100 patient-years.

    3. Compute proportional reporting ratio (PRR).

    4. Identify any term with PRR > 2 and at least three events.

    5. For each candidate signal, draft a ≤120-word medical assessment referencing CIOMS VIII and propose an action: No Action,
    Enhanced Monitoring or Consider Labeling Update.


    Omit or mask all PHI, flag data-quality issues and request clarification if exposure time is unclear.'
- role: user
  content: '- `{{ae_listing}}` – adverse-event listings in CSV

    - `{{benchmark_rates}}` – historical placebo incidence rates


    Output format: Valid JSON array with keys: `PT`, `PRR`, `nEvents`, `Assessment`, `RecommendedAction`.'
testData: []
evaluators: []