Automating Pharmacovigilance Workflows for Compliance

This case study outlines the implementation of an AI-powered solution by a global pharmaceutical organization to enhance their Pharmacovigilance (PV) workflows in compliance with Health Canada’s Foreign Risk guidance. The PV team faced challenges such as information overload, incomplete reporting, and the absence of a systematic approach, which increased the risk of non-compliance with regulations. The solution involved creating a centralized repository for validated content, enabling quick access to risk communications and facilitating systematic reporting to Health Canada. The implementation resulted in a user-friendly dashboard that reduced the time spent searching for intelligence by 73%, allowing the team to focus on identifying relevant risk communications and safety signals. The flexibility of the solution also enabled the expansion of coverage to additional Health Authorities, ensuring comprehensive monitoring of safety intelligence. Overall, the case study demonstrates how the integration of technology and human expertise can optimize compliance processes in the pharmaceutical industry.