Pharmacovigilance Assistant: An Agentic Workflow for Reproducible Drug Safety Summaries

We present an agentic workflow that converts heterogeneous safety evidence into concise, reproducible drug summaries. While automated FAERS summarization, retrieval-augmented generation, and tool-driven agents exist in isolation, our contribution lies in their integration within a schema-aware, deterministic pipeline with explicit versioning and pharmacokinetic contextualization. The system queries FAERS via OpenFDA, integrates curated cytochrome P450 mappings, and can retrieve recent PubMed records. It normalizes fields, computes predefined aggregates, assesses enzyme overlap between index drugs and frequent co-medications, and generates constrained narratives and figures directly from computed tables. Applied to 110 drugs, the workflow recovered clear cross-drug patterns in severe outcomes and identified per-drug leaders for death and hospitalization. Case examples for clopidogrel and voriconazole illustrate how co-reporting patterns combined with CYP context provide mechanistic framing without implying causality. Deterministic execution, versioned queries, and cached responses enable exact reruns and audit. The workflow produces structured safety briefs that support safety committee review, early signal triage, and the selection of targets for confirmatory pharmacoepidemiologic studies.