P204: Automating Pharmacovigilance Workflows through AI to Improve Patient Safety Outcomes
Poster Presenter
Rishi Verma
Medical Director
Roche & Stethy Australia
Objectives
1. Identify best practices for implementing AI-driven Adverse Event detection in pharmacovigilance.
2. Assess the impact of AI automation on patient safety, reporting compliance, and administrative workload.
3. Outline strategies for measuring and sustaining improvements in AE detection accuracy
Method
After deploying AI algorithms for Adverse Event (AE) detection within Roche's Pharmacovigilance division, we collected quantitative data over a 12-month period to assess performance improvements. The AI system achieved a 98.6% accuracy in AE detection, a significant increase from the previous rate of 85% with manual processes. Reporting compliance reached 100%, eliminating delays and ensuring timely submissions to regulatory authorities.
Administrative burden was reduced by 250%, measured by the decrease in personnel hours dedicated to AE detection and reporting tasks. This allowed staff to focus on more critical analyses and decision-making processes. The total number of detected AEs increased by 35%, indicating that the AI system effectively identified events that might have been overlooked manually.
We also observed a 40% reduction in the time taken to process each AE report, enhancing the overall efficiency of pharmacovigilance operations. Employee satisfaction scores increased by 20%, reflecting improved workflows and reduced repetitive tasks. These improvements confirm the hypothesis that AI automation enhances pharmacovigilance processes by increasing accuracy, compliance, and efficiency.
The study demonstrates that integrating AI into pharmacovigilance not only improves patient safety outcomes through better AE detection but also optimizes resource utilization. The AI system's ability to process large volumes of data quickly and accurately has transformed the pharmacovigilance landscape within Roche, setting a precedent for future technological integrations in the industry.
