A practical, end-to-end guide to pharmacovigilance signal management, from the first statistical alert to the final regulatory decision.

Most drug safety texts explain how to find a signal. Far fewer show what happens next: how a signal is validated, prioritized, assessed, weighed against benefit, escalated, and closed with a record that holds up. Signal Management in Pharmacovigilance covers that whole lifecycle in one volume. It is written by a physician-scientist whose safety career spans both pharmaceuticals and medical devices.

The book follows a set of fictional products from their first safety report to a final decision, with case data that stay consistent from chapter to chapter. Along the way, it walks through the core methods step by step: statistical screening of safety databases, comparing observed with expected case counts, timing analysis, causality assessment, and deciding which signals to act on first. It explains the European and US regulatory frameworks that govern this work, including recent changes to how signals must be reported and how the FDA collects adverse event data.

Each chapter ends with a short "Bottom Line": one key takeaway and the concrete actions that follow, with who owns each one and what they produce. Figures, tables, knowledge-check questions with a full answer guide, and ready-to-use templates and worksheets help readers put the methods into practice.

The book is written for safety physicians and scientists, pharmacovigilance and regulatory professionals, clinical development teams, and students preparing for a career in drug safety. Whether you are building a signal management process, defending one at inspection, or making your first signal assessment, it gives you the methods, the regulatory framework, and the judgment to move from alert to action with confidence.