{"id":24706,"date":"2019-08-22T21:43:11","date_gmt":"2019-08-22T19:43:11","guid":{"rendered":"http:\/\/www.veeva.com\/eu\/?post_type=resources&#038;p=24706"},"modified":"2026-06-23T01:50:12","modified_gmt":"2026-06-22T23:50:12","slug":"veeva-safety-product-brief","status":"publish","type":"resources","link":"https:\/\/www.veeva.com\/eu\/resources\/veeva-safety-product-brief\/","title":{"rendered":"³Ô¹Ï±¬ÁÏ Safety Features Brief"},"content":{"rendered":"<style>\n.veeva-2024 .fa-ul li p {\nmargin-top:5px;\n}\n.veeva-2024 .content-block .fa-check-circle {\ncolor: #f7981d;\nfont-weight: 400;\nfont-size:20px;\n}\n@media (min-width:768px) {\n.veeva-2024 .hero-centered {\npadding: 100px 0;\n}\n}\n@media (min-width:992px) {\n.veeva-2024 .content-block {\nmargin-top: 6rem;\n}\n}\n.veeva-2024 .content-block__sidebar {\ndisplay:none;\n}<\/p>\n<p>.veeva-2024 .content-block__content .stat-box {\nbackground: #eef1f5;\ndisplay: inline-block;\npadding: 10px 30px;\nborder-radius: 16px;\nfont-size: 18px;\nmargin: 5px 5px 20px 5px;\nfont-weight: 500;\n}\n.veeva-2024 .content-block__content .stat-box span {\ncolor:#f5670e;\nfont-weight:600;\n}\n\/* to remove the mobile dropdown *\/\n.veeva-2024 .form-dropdown {\ndisplay: none;\n}\n<\/style>\n<p><img decoding=\"async\" class=\"img-right d-none d-lg-block\" alt=\"\" src=\"\/wp-content\/uploads\/2025\/07\/vault-safety-features-brief-figure-1.png\"><\/p>\n<p>³Ô¹Ï±¬ÁÏ Safety is the only modern application for the collection, management, submission, and real-time oversight of adverse events.<\/p>\n<p>Outsourcing with legacy systems behind corporate firewalls has left organizations with insufficient visibility, fragmented data, and ineffective access to safety information.<\/p>\n<p>With the ability to manage adverse event information and documentation in a single system, ³Ô¹Ï±¬ÁÏ Safety enables sponsors to make faster, more informed decisions and improve compliance throughout the product lifecycle.<\/p>\n<p><img decoding=\"async\" class=\"img-right d-block d-lg-none\" alt=\"\" src=\"\/wp-content\/uploads\/2025\/07\/vault-safety-features-brief-figure-1.png\"><\/p>\n<h2>Benefits<\/h2>\n<ul class=\"fa-ul\">\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Streamline case management<\/strong> <br \/>\n   Gain efficiencies with a modern safety application built for today\u2019s regulations and best practices.\u0007<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Unified<\/strong> <br \/>\n   A single cloud platform for safety, clinical, regulatory, and quality eliminates silos and drives end-to-end safety processes. \u0007<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Improve oversight to reduce risk<\/strong> <br \/>\n   Real-time reports and dashboards and seamless collaboration with partners provides the necessary visibility for risk mitigation and compliance. <\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Stay current<\/strong> <br \/>\n   Access new capabilities and the latest regulatory requirements with easy and automatic upgrades.<\/p>\n<\/li>\n<\/ul>\n<h2>Features<\/h2>\n<ul class=\"fa-ul\">\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Global case management<\/strong> <br \/>\n   Manage all adverse events in one solution while supporting regional privacy requirements, and easily process in parallel global \/ domestic initial and follow up cases.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Low touch case processing<\/strong> <br \/>\n   Automate triaging, processing, and submissions of cases with advanced capabilities including auto-promotion, always serious lists, case qualification, expectedness, auto-calculation, pre-populations, and determined destinations.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Built on modern industry standards<\/strong> <br \/>\n   Based on the latest International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Efficacy Guidelines (E2B R3, E2B R2) and International Organization for Standardization for the Identification of Medicinal ³Ô¹Ï±¬ÁÏ (ISO IDMP) standards to align with Good Pharmacovigilance Practices (GVP) in the European Union.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Dictionary support<\/strong> <br \/>\n   Supports global standard World Health Organization Drug Dictionary (WHODrug C3), Medical Dictionary for Regulatory Activities (MedDRA), Unified Code for Units of Measure (UCUM), International Medical Device Regulators Forum (IMDRF), and regional requirements for Japan\u2019s Iyakuhinmei Data File (IDF) and Korea\u2019s Ministry of Food and Drug Safety (MFDS). Features automated drug code mapping via WHODrug Cross Reference Tool Japan and WHODrug Link Korea.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Health authority reporting and submissions<\/strong> <br \/>\n   Provides configurable reporting rules to support electronic submission of Individual Case Safety Reports (ICSR) and periodic reports to global health authorities and partners.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Active monitoring and notifications<\/strong> <br \/>\n   Active monitoring with automated notification of issue detection for Adverse Events of Special Interest (AESI), Designated Medical Event (DMI\u2019s), and Watchlists.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Interactive dashboards and reports<\/strong> <br \/>\n   Drill down through real-time interactive dashboards and reports to view and track data such as case processing efficiency and ensure timely submissions.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Configurable case management workflows<\/strong> <br \/>\n   Automate and track cases with standard and configurable workflows. Provides assignment, routing, email notifications, escalation, and tracking of tasks for groups or individuals.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Literature management<\/strong> <br \/>\n   Streamline literature review processes with bulk intake of literature references, reducing manual effort and speeding the time to identify possible ICSRs and safety signals. Seamlessly transfer ICSR data from a literature article to the ³Ô¹Ï±¬ÁÏ Safety inbox for case processing.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Connected safety platform<\/strong> <br \/>\n   ³Ô¹Ï±¬ÁÏ Safety is seamlessly connected with Clinical Operations, EDC, RIM, Quality, and MedInquiry.<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span>\n<p><strong>Part of the ³Ô¹Ï±¬ÁÏ Development Cloud<\/strong> <br \/>\n   Eliminate silos and drive end-to-end safety processes with a single cloud platform for safety, clinical, regulatory, and quality.<\/p>\n<\/li>\n<\/ul>\n<h2>Vault Platform<\/h2>\n<p>³Ô¹Ï±¬ÁÏ Vault is the first cloud platform built from the ground up to meet the rigorous content management requirements of the life sciences industry. With a modern user experience and uniquely designed for both content and data on a single platform, organizations can seamlessly manage end-to-end processes.<\/p>\n<p>The Vault Platform leverages the latest in cloud technology and is delivered and accessed through the web for greater ease-of- use. Hosted at SOC I Type II and ISO 27001 certified global data centers, every release is IQ and OQ qualified \u2013 reducing the validation efforts.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Streamline collection, management, and gain real-time oversight of adverse events.<\/p>\n","protected":false},"featured_media":28359,"parent":0,"template":"","class_list":["post-24706","resources","type-resources","status-publish","has-post-thumbnail","hentry","resource-social-hide-social-icons","resource-area-20-safety","resource-product-20-safety2","resource-type-product-briefs"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/24706"}],"collection":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources"}],"about":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/types\/resources"}],"version-history":[{"count":4,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/24706\/revisions"}],"predecessor-version":[{"id":93447,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/24706\/revisions\/93447"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media\/28359"}],"wp:attachment":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media?parent=24706"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}