Pharmacovigilance Signal Detection overview

Detects and evaluates safety signals from post-market drug surveillance -- ingesting adverse event reports from FAERS, EudraVigilance, and spontaneous reporting systems, running disproportionality analysis (PRR, ROR, BCPNN) to identify statistically elevated drug-event combinations, triaging signals by clinical seriousness and novelty, correlating findings with published literature and clinical trial safety databases, and escalating confirmed signals to safety evaluation boards. Produces signal detection reports, cumulative review summaries, and PADER/PSUR contributions. Excludes benefit-risk assessment decisions.