What problem does it solve?
Identifying rare or emerging adverse drug events is difficult because clinical trials lack the statistical power to detect them, and manual pharmacovigilance analysis across FAERS reports, FDA labels, and literature is slow and error-prone. This Skill automates quantitative signal detection so safety analysts can assess drug risk with statistical rigor.
Core Features & Use Cases
- Disproportionality Signal Detection: Calculates PRR, ROR, and IC with 95% confidence intervals for each adverse event from FAERS data, classifying signal strength as Strong, Moderate, Weak, or None.
- Multi-Source Safety Triangulation: Combines FAERS reports, FDA label sections (boxed warnings, contraindications, interactions), OpenTargets, DrugBank, PharmGKB pharmacogenomics, and PubMed literature into one assessment.
- Quantitative Safety Signal Score: Produces a 0-100 risk score with T1-T4 evidence grading and a structured markdown report including monitoring recommendations.
- Use Case: Ask whether pembrolizumab is associated with myocarditis, and receive PRR/ROR/IC statistics, demographic stratification, FDA label cross-checks, and literature evidence in a single report.
Quick Start
Ask the agent to detect adverse event signals for atorvastatin and generate a full pharmacovigilance report with a Safety Signal Score.