Transforming pharmacovigilance systems

The evolving pharmacovigilance landscape

For the past several decades, the pharmacovigilance function has been responsible for collecting, processing, and reporting adverse events (AEs) and other product safety information to regulators. PV’s process-heavy nature often drove companies to select associated safety systems based on their ability to organize data and optimize efficiency, typically leaving limited system options.

Today’s PV function is being reshaped by numerous global health care trends. While many of these trends are delivering considerable benefits, they also are exerting pressure on biopharmaceutical companies’ existing safety systems.

As a result, many organizations are facing significant cost burdens to maintain and upgrade these systems, even though—under the current safety system paradigm—the same trends may cause the costs of traditional upgrade approaches to grow disproportionally versus benefits. This, in turn, is prompting many biopharma companies to consider how automation, cognitive technologies, and advanced analytics may help them get more from their PV systems—to progress from merely analyzing, formatting, and submitting reports on patient- and provider-supplied case processing and signaling data to creating a next-generation digital learning system that efficiently and cost-effectively increases product quality and patient safety.