Apr 7, 2025
Automation is increasingly being recognized as a powerful tool in pharmacovigilance (PV), particularly in the processing of Individual Case Safety Reports (ICSRs). With the high costs, large workforce demands, and quality risks involved in manual processing, automation—via AI, ML, RPA, and cognitive computing—offers a transformative solution. From case intake and processing to reporting, automation can streamline operations, reduce errors, and enhance compliance. However, regulatory risks and the complexity of medical evaluation still pose implementation challenges.