Overview of Veeva Vault Safety
Veeva Vault Safety offers a cutting-edge solution for managing individual case safety reports (ICSR) in the pharmaceutical industry. This system supports the intake, processing, and submission of adverse events related to both clinical trials and post-marketed products. It provides a unified platform for sponsors and Contract Research Organizations (CROs) to handle global and domestic adverse events for various types of products, including drugs, biologics, vaccines, devices, and combination products. The platform's built-in gateway connections and reporting rules streamline the management of case submissions to health authorities and distribution to partners.
Key Features and Benefits
One of the key features of Veeva Vault Safety is its central coding dictionary management, which automates updates related to MedDRA, WHODrug, and EDQM on a semi-annual basis. This ensures that users always have access to the most current coding standards and regulatory requirements. The system enables users to streamline adverse event management processes, automate intake procedures, and gain efficiencies in ICSR processing from intake to submission. With seamless end-to-end safety processes, Veeva Vault Safety facilitates seamless data sharing between safety operations and other departments such as clinical, quality, and regulatory functions through Vault Connections.
Customer Testimonials and Success Stories
Customers like Merck have experienced significant improvements in safety oversight and case processing through the implementation of Veeva Vault Safety. According to Tawny Landtiser, a Pharmacovigilance manager at Dermavant, the system is user-friendly, seamless, and intuitive, offering a unique experience compared to other solutions. The platform has helped organizations enhance safety data control, improve oversight, and adhere to new regulatory requirements efficiently.
Resources and Further Learning Opportunities
Veeva provides various resources for users to explore and learn more about pharmacovigilance best practices and the capabilities of Vault Safety. These resources include blog posts, articles, case studies, videos, and product sheets. By leveraging these materials, organizations can enhance their understanding of safety intelligence, streamline package insert management, improve data control when outsourcing, and connect safety data across the value chain to enhance patient safety.