This article examines how artificial intelligence supports drug safety activities, from adverse event detection to safety data analytics, while regulatory oversight, human decision authority, and clear AI governance frameworks remain central to compliant pharmacovigilance operations.

This article explores pharmacovigilance as a structured safety governance system that integrates safety data, regulatory oversight, and decision accountability. It explains how governance-driven models improve inspection readiness, strengthen regulatory trust, and support consistent post-marketing safety decisions across the product lifecycle.