{"id":178,"date":"2019-10-26T11:00:33","date_gmt":"2019-10-26T11:00:33","guid":{"rendered":"http:\/\/eurekainfomed.it\/?page_id=178"},"modified":"2026-07-09T09:45:28","modified_gmt":"2026-07-09T09:45:28","slug":"pharmacovigilance","status":"publish","type":"page","link":"https:\/\/eurekainfomed.it\/en\/pharmacovigilance\/","title":{"rendered":"Pharmacovigilance"},"content":{"rendered":"

Pharmacovigilance: a continuous commitment to patient safety<\/h2>\n

 <\/p>\n

\n

What it is<\/strong><\/h3>\n

Pharmacovigilance is an essential monitoring activity aimed at detecting, assessing, understanding, and preventing adverse effects associated with medicinal products and medical devices. Through this activity, pharmaceutical companies ensure a continuous and well-documented evaluation of the benefit\u2013risk profile of their products.<\/p>\n

It is a complex process that requires in-depth knowledge of current regulations at both local and European levels, as well as specific expertise in data analysis and management, and in the preparation of documentation to be submitted to national and international regulatory authorities.<\/p>\n

Our strengths<\/strong><\/h3>\n

➕ Timely and rigorous service, always aligned with the latest regulations
\n➕ Speed and accuracy in handling reports and preparing documentation
\n➕ Operational flexibility to meet different client needs
\n➕ Ongoing, qualified support ensuring high quality standards
\n➕ Continuous monitoring to ensure the safety and efficacy of pharmaceutical products<\/p>\n

How we can help you<\/strong><\/h3>\n
    \n
  • Acting as QPPV \/ Local Contact Person \/ PVQA<\/strong><\/li>\n
  • Preparation of periodic documentation:\n
      \n
    • Periodic Safety Update Reports (PSUR)<\/li>\n
    • Risk Management Plans (RMP)<\/li>\n<\/ul>\n<\/li>\n
    • Management of the pharmacovigilance system and Pharmacovigilance System Master File (PSMF)<\/strong><\/li>\n
    • Signal detection<\/li>\n
    • Monitoring of national and international literature and regulatory websites<\/li>\n
    • Management of ICSRs (Individual Case Safety Reports)<\/strong><\/li>\n
    • Entry and maintenance of the product dictionary (xEVMPD<\/strong>)<\/li>\n
    • Pharmacovigilance support in clinical trials<\/li>\n<\/ul>\n

      Areas of expertise<\/strong><\/h3>\n

      ✅ Medicinal products
      \n✅ Medical devices<\/p>\n

      Target clients<\/strong><\/h3>\n

      ✅ Italian and international companies and agencies
      \n✅ Companies and agencies holding foreign marketing authorizations (MAHs)<\/p>\n<\/div>\n

      \n","protected":false},"excerpt":{"rendered":"

      Pharmacovigilance: a continuous commitment to patient safety   What it is Pharmacovigilance is an essential monitoring activity aimed at detecting, assessing, understanding, and preventing adverse effects associated with medicinal products…<\/p>\n","protected":false},"author":1,"featured_media":10103,"parent":0,"menu_order":27,"comment_status":"closed","ping_status":"closed","template":"page-sidebar.php","meta":{"footnotes":""},"class_list":["post-178","page","type-page","status-publish","has-post-thumbnail"],"yoast_head":"\nPharmacovigilance: A Continuous Commitment to Patient Safety<\/title>\n<meta name=\"description\" content=\"Discover how pharmacovigilance ensures patient safety through continuous monitoring, risk assessment, regulatory compliance.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/eurekainfomed.it\/en\/pharmacovigilance\/\" \/>\n<meta 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