A New Pharmacovigilance Ecosystem: Automation, AI, And Continuous Improvement

By Humaira Qureshi, Qinecsa

Pharmacovigilance (PV) is evolving from a necessary but reactive safety function to a proactive, value-driven discipline, harnessing new technologies to improve efficiency and data utility. As PV faces increasing data volumes and complexities in clinical trials, automation becomes essential. To successfully implement these technologies, cultural shifts and robust processes are crucial. Organizations must merge expertise in new technologies with PV knowledge, enhancing strategic sourcing and reducing reliance on manual processes. Innovations like robotic process automation and artificial intelligence can significantly streamline case processing and risk assessments. However, challenges still exist for growing PV's potential, including outdated practices and cultural resistance to change. Strong leadership, clear communication about PV’s importance, and consistent progress measurement will foster engagement and acceptance among staff. Ultimately, a successful PV transformation hinges on a cyclical approach, leveraging technology while nurturing a supportive culture that prioritizes patient safety and proactive risk management.