AI is transforming pharmacovigilance by streamlining case processing, literature surveillance, safety detection, and signal management. Regulators like the FDA are actively shaping guidance, with recent initiatives including the Emerging Drug Safety Technology Program and 2025 draft guidelines for AI in decision-making. IQVIA’s Vigilance Platform embeds AI across detection, submissions, and reporting, supported by Healthcare-grade AI with human-in-the-loop governance to ensure reliability and compliance. The shift reduces manual processing, reallocates resources to specialized roles, and enhances efficiency while keeping patient safety central. Collaboration with regulators and providers ensures responsible adoption.

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