In the increasingly scrutinized and budget-constrained environment of the New Health, the pharmacovigilance function must be as compliant and cost-effective as possible. As such, pharmacovigilance organizations must be efficiently run operations, driven by a capacity planning strategy to create a seamless, integrated framework for adverseevent signal detection and reporting. The end result will lead to lower surveillance costs throughout the product development lifecycle for biopharmaceutical companies, provide a more rapid system for identifying and communicating potential safety issues, and ultimately enhance and protect patient safety.

For pharmacovigilance organizations to become a value-added partner in the biopharmaceuticals industry, they need to focus on doing three things exceptionally well: 1) Run pharmacovigilance operations as well-managed, metrics-run businesses, with an eye on controlling costs while increasing quality and compliance; 2) Further develop processes and tools that will leverage collected data to improve business decisions, and; 3) Continue to build deep skills in signal detection — migrating from a reactive to an anticipating organization.

About the Author

Bill Truhe, MBA, leads the pharmacovigilance practice for Consulting at Quintiles. He has more than 20 years experience in biopharmaceuticals, with a focus on process, technology, and organizational efficiency and design. Prior to joining Quintiles, Bill was a Board Member and Vice President of Safety Data Management & Quality Systems in Johnson & Johnson’s global drug safety organization.