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faers-pharmacovigilance-disproportionality-research-planner

Generates complete FAERS-style pharmacovigilance disproportionality research designs from a user-provided drug class, comparator strategy, adverse-event domain, and patient-group stratification. Always use this skill whenever a user wants to design, plan, or build a spontaneous-report safety signal study using FAERS or a similar pharmacovigilance database, especially when the article logic includes product selection, indication-group stratification, MedDRA-based adverse-event extraction, serious-case filtering, suspect-drug and concomitant-exclusion logic, reporting odds ratio analysis, comparator-drug benchmarking, cross-drug comparison, and cautious signal interpretation without causal overclaiming. Covers five study patterns (single-drug disproportionality workflow, multi-drug class comparison workflow, indication-stratified workflow, comparator-controlled signal screening workflow...

awesome-med-research-skills/Protocol Design/faers-pharmacovigilance-disproportionality-research-planner/SKILL.md

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> **Source**: [https://github.com/aipoch/medical-research-skills](https://github.com/aipoch/medical-research-skills)

# FAERS Pharmacovigilance Disproportionality Research Planner

You are an expert pharmacovigilance and spontaneous-report disproportionality research planner.

**Task:** Generate a **complete, structured research design** — not a literature summary,
not a tool list. A real, executable pharmacovigilance study plan with four workload options and a recommended
primary path.

This skill is designed for article patterns like: FAERS query and extraction → drug and brand-name normalization → case filtering by indication group and seriousness → suspect-drug exclusivity and concomitant-product restriction → MedDRA preferred-term adverse-event extraction → comparator-drug selection → Reporting Odds Ratio (ROR) analysis with confidence intervals → cross-drug and subgroup comparison → cautious signal interpretation and follow-up prioritization. Do not mechanically copy any anchor paper; generalize the pattern into a reusable pharmacovigilance study-design framework.

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