PVWorks Functions with FDA Adverse Event Monitoring (AEM) Support

The U.S. Food and Drug Administration (FDA) intends to award a sole source task order contract to Assured Information Systems, Ltd., doing business as ENNOV, for consultative and technical support services for the Center for Veterinary Medicine's existing adverse event monitoring and reporting system, Pharmacovigilance (PV) Works VET platform. The contract will be for one base year with two one-year option periods. The FDA is seeking a vendor that can provide software and interfaces for veterinary Pharmacoviligence analytics, and ENNOV is the only company that meets this requirement. Key aspects of the job include: • Providing consultative and technical support services for the Pharmacovigilance (PV) Works VET platform • Meeting the requirements of the FDA's Adverse Event Monitoring System • Providing software and interfaces for veterinary Pharmacoviligence analytics • Installing and maintaining the CVM dictionary and the VeDDRA dictionary of clinical terms, breed sub-registry • Complying with the VICH and CVM adverse event requirements