Enhancing Pharmaceutical Safety with Veeva Vault Safety

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Enhancing Pharmaceutical Safety with Veeva Vault Safety

Introduction to Veeva Vault Safety

Veeva Vault Safety is a cutting-edge solution designed to revolutionize the management of individual case safety reports (ICSR) within the pharmaceutical industry. This robust system facilitates the intake, processing, and submission of adverse events for both clinical and post-marketed products, offering a global and modern approach to adverse event management.

Comprehensive Adverse Event Management

With Veeva Vault Safety, sponsors and Contract Research Organizations (CROs) can seamlessly handle adverse events related to various products such as drugs, biologics, vaccines, devices, and combination products. The system's built-in gateway connections and reporting rules ensure efficient submission management of cases to health authorities and distribution to partners, streamlining the entire process.

Automated Coding Dictionary Management

One of the key features of Veeva Vault Safety is its central coding dictionary management, which automates the updates for MedDRA, WHODrug, and EDQM dictionaries semi-annually. This automation ensures that the coding process remains up-to-date and compliant with regulatory standards, reducing the risk of errors and enhancing data accuracy.

Benefits of Using Vault Safety

Veeva Vault Safety offers a range of benefits to its users, including streamlined adverse event management, automated intake through submissions, end-to-end safety processes, global case view and oversight, and continuous updates to meet new regulatory requirements. This comprehensive solution aims to improve operational efficiencies, ensure compliance, and enhance overall safety oversight for pharmaceutical companies.

Customer Success Stories

Customers like Merck have experienced significant improvements in safety oversight and case processing by implementing Veeva Vault Safety. Testimonials from Pharmacovigilance managers, such as Tawny Landtiser from Dermavant, highlight the user-friendly nature and seamless experience of the system, underscoring its effectiveness in real-world applications.

Resources and Further Learning

Veeva provides a wealth of resources for those interested in learning more about Vault Safety, including blog posts, articles, case studies, and videos. These resources cover topics like package insert management, safety data control, and building a safety intelligence unit, offering valuable insights into optimizing pharmacovigilance practices within the industry.

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