AI is revolutionizing pharmacovigilance with rapid data analysis and signal detection from vast sources like EHRs and social media. But can it replace clinical insight?
While AI tools enhance efficiency, they often miss rare adverse events or raise false alarms that experts can easily interpret. Regulatory bodies like EMA, FDA, and MHRA stress that AI should support—not replace—human judgment in drug safety.
As Kimberly Gold of Genentech states, “AI empowers people, but humans remain in control.” In pharmacovigilance, accountability and clinical wisdom are irreplaceable. AI is a tool, not the decision-maker.