Orchestrating generative AI in pharmacovigilance: predicting and preempting the unpredictable.

The advent of generative artificial intelligence (GenAI) has introduced both remarkable opportunities and significant challenges in the field of pharmacovigilance (PV). This perspective review reflects on emerging trends, practical use cases, and conceptual frameworks shaping the integration of GenAI in high-risk domains such as drug and vaccine safety monitoring. We draw on current experiments and early real-world applications to examine the potential benefits, inherent risks, and propose a framework for integrating GenAI into PV systems, emphasizing the necessity of rigorous testing, human oversight, and ethical considerations. Our goal is to support PV professionals and stakeholders in navigating this rapidly evolving landscape by identifying promising strategies and implementation pathways.