{"id":3412,"date":"2025-10-06T11:12:07","date_gmt":"2025-10-06T09:12:07","guid":{"rendered":"https:\/\/fgk-group.com\/?post_type=services-fgk-cro&#038;p=3412"},"modified":"2026-05-08T12:52:19","modified_gmt":"2026-05-08T10:52:19","slug":"pharmakovigilanz","status":"publish","type":"services-fgk-cro","link":"https:\/\/fgk-group.com\/de\/fgk-cro\/dienstleistungen\/pharmakovigilanz\/","title":{"rendered":"Pharmakovigilanz"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"3412\" class=\"elementor elementor-3412 elementor-450\" data-elementor-post-type=\"services-fgk-cro\">\n\t\t\t\t<div class=\"elementor-element elementor-element-317cd66 e-flex e-con-boxed e-con e-parent\" data-id=\"317cd66\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a154a25 elementor-widget elementor-widget-heading\" data-id=\"a154a25\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Ihre Spezialisten f\u00fcr Risikominimierung<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bf77625 elementor-widget elementor-widget-text-editor\" data-id=\"bf77625\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Pharmakovigilanz oder Safety Monitoring bedeutet, jedes einzelne unerw\u00fcnschte Ereignis zu erfassen, das w\u00e4hrend Ihrer Studie auftritt. Diese Masse an Daten muss vollst\u00e4ndig gemeldet, aber auch verstanden werden. Nur dann k\u00f6nnen die Risiken reduziert und eine angemessene Kennzeichnung erstellt werden.<\/p><p>Wir k\u00f6nnen die von Ihnen bevorzugte, international verwendete einheitliche Kodierung verwenden und wissen, wie man die entsprechenden Daten analysiert. Wir halten uns an alle beh\u00f6rdlichen Meldeverpflichtungen hinsichtlich Schwere und Kausalit\u00e4t von unerw\u00fcnschten Ereignissen, die konservativste Bewertung und die f\u00fcr diese Prozesse geltenden Meldefristen.<\/p><p>Regelm\u00e4\u00dfige Sicherheitsberichte werden bei den zust\u00e4ndigen Beh\u00f6rden eingereicht, Safety Notifications an einen vordefinierten Verteiler weitergeleitet. Unsere \u00c4rzte stehen den Pr\u00fcf\u00e4rzten auch beratend zur Seite.<\/p><p>Wenn Sie von unserer Safety-Erfahrung und der etablierten Zusammenarbeit mit Beh\u00f6rden auf beiden Seiten des Atlantiks profitieren m\u00f6chten, finden Sie weitere Informationen unter<a href=\"\/de\/fgk-pv\/\"><strong> www.fgk-group.com\/de\/pv\/<\/strong><\/a>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-729bf57 elementor-widget elementor-widget-heading\" data-id=\"729bf57\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Was wir in der Abteilung Pharmakovigilanz tun<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f13d44b elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"f13d44b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Wir <strong>\u00fcberwachen<\/strong> Studien hinsichtlich der Sicherheit von Arzneimitteln<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Wir <strong>kodieren<\/strong> unerw\u00fcnschte Ereignisse und Begleitmedikation gem\u00e4\u00df MedDRA und der WHO-Arzneimitteldatenbank<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Wir <strong>bewerten<\/strong> und <strong>verstehen<\/strong> beobachtete unerw\u00fcnschte Ereignisse<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Wir <strong>melden<\/strong> relevante Ereignisse an Zulassungsbeh\u00f6rden und Ethikkommissionen und erstellen Sicherheitsberichte (DSURs)<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Wir <strong>kommunizieren<\/strong> mit Drug Safety Monitoring Committees und Pr\u00fcf\u00e4rzten<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"parent":0,"menu_order":0,"template":"","class_list":["post-3412","services-fgk-cro","type-services-fgk-cro","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Pharmakovigilanz - FGK Group<\/title>\n<meta name=\"description\" content=\"Pharmacovigilanz: Studien\u00fcberwachung \u2713MeDRA Codierung \u2713 DSURs nach Zulassung und Markteinf\u00fchrung.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/fgk-group.com\/de\/fgk-cro\/dienstleistungen\/pharmakovigilanz\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharmakovigilanz - FGK Group\" \/>\n<meta property=\"og:description\" content=\"Pharmacovigilanz: Studien\u00fcberwachung \u2713MeDRA Codierung \u2713 DSURs nach Zulassung und Markteinf\u00fchrung.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/fgk-group.com\/de\/fgk-cro\/dienstleistungen\/pharmakovigilanz\/\" \/>\n<meta property=\"og:site_name\" content=\"FGK Group\" \/>\n<meta property=\"article:modified_time\" content=\"2026-05-08T10:52:19+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Gesch\u00e4tzte Lesezeit\" \/>\n\t<meta name=\"twitter:data1\" content=\"2\u00a0Minuten\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/fgk-cro\\\/dienstleistungen\\\/pharmakovigilanz\\\/\",\"url\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/fgk-cro\\\/dienstleistungen\\\/pharmakovigilanz\\\/\",\"name\":\"Pharmakovigilanz - FGK Group\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/#website\"},\"datePublished\":\"2025-10-06T09:12:07+00:00\",\"dateModified\":\"2026-05-08T10:52:19+00:00\",\"description\":\"Pharmacovigilanz: Studien\u00fcberwachung \u2713MeDRA Codierung \u2713 DSURs nach Zulassung und Markteinf\u00fchrung.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/fgk-cro\\\/dienstleistungen\\\/pharmakovigilanz\\\/#breadcrumb\"},\"inLanguage\":\"de\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/fgk-group.com\\\/de\\\/fgk-cro\\\/dienstleistungen\\\/pharmakovigilanz\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/fgk-cro\\\/dienstleistungen\\\/pharmakovigilanz\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Services\",\"item\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/fgk-cro\\\/dienstleistungen\\\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Pharmakovigilanz\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/#website\",\"url\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/\",\"name\":\"FGK Group\",\"description\":\"Just another WordPress site\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"de\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Pharmakovigilanz - FGK Group","description":"Pharmacovigilanz: Studien\u00fcberwachung \u2713MeDRA Codierung \u2713 DSURs nach Zulassung und Markteinf\u00fchrung.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/fgk-group.com\/de\/fgk-cro\/dienstleistungen\/pharmakovigilanz\/","og_locale":"de_DE","og_type":"article","og_title":"Pharmakovigilanz - FGK Group","og_description":"Pharmacovigilanz: Studien\u00fcberwachung \u2713MeDRA Codierung \u2713 DSURs nach Zulassung und Markteinf\u00fchrung.","og_url":"https:\/\/fgk-group.com\/de\/fgk-cro\/dienstleistungen\/pharmakovigilanz\/","og_site_name":"FGK Group","article_modified_time":"2026-05-08T10:52:19+00:00","twitter_card":"summary_large_image","twitter_misc":{"Gesch\u00e4tzte Lesezeit":"2\u00a0Minuten"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/fgk-group.com\/de\/fgk-cro\/dienstleistungen\/pharmakovigilanz\/","url":"https:\/\/fgk-group.com\/de\/fgk-cro\/dienstleistungen\/pharmakovigilanz\/","name":"Pharmakovigilanz - FGK Group","isPartOf":{"@id":"https:\/\/fgk-group.com\/de\/#website"},"datePublished":"2025-10-06T09:12:07+00:00","dateModified":"2026-05-08T10:52:19+00:00","description":"Pharmacovigilanz: Studien\u00fcberwachung \u2713MeDRA Codierung \u2713 DSURs nach Zulassung und Markteinf\u00fchrung.","breadcrumb":{"@id":"https:\/\/fgk-group.com\/de\/fgk-cro\/dienstleistungen\/pharmakovigilanz\/#breadcrumb"},"inLanguage":"de","potentialAction":[{"@type":"ReadAction","target":["https:\/\/fgk-group.com\/de\/fgk-cro\/dienstleistungen\/pharmakovigilanz\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/fgk-group.com\/de\/fgk-cro\/dienstleistungen\/pharmakovigilanz\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/fgk-group.com\/de\/"},{"@type":"ListItem","position":2,"name":"Services","item":"https:\/\/fgk-group.com\/de\/fgk-cro\/dienstleistungen\/"},{"@type":"ListItem","position":3,"name":"Pharmakovigilanz"}]},{"@type":"WebSite","@id":"https:\/\/fgk-group.com\/de\/#website","url":"https:\/\/fgk-group.com\/de\/","name":"FGK Group","description":"Just another WordPress site","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/fgk-group.com\/de\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"de"}]}},"_links":{"self":[{"href":"https:\/\/fgk-group.com\/de\/wp-json\/wp\/v2\/services-fgk-cro\/3412","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/fgk-group.com\/de\/wp-json\/wp\/v2\/services-fgk-cro"}],"about":[{"href":"https:\/\/fgk-group.com\/de\/wp-json\/wp\/v2\/types\/services-fgk-cro"}],"version-history":[{"count":16,"href":"https:\/\/fgk-group.com\/de\/wp-json\/wp\/v2\/services-fgk-cro\/3412\/revisions"}],"predecessor-version":[{"id":10347,"href":"https:\/\/fgk-group.com\/de\/wp-json\/wp\/v2\/services-fgk-cro\/3412\/revisions\/10347"}],"wp:attachment":[{"href":"https:\/\/fgk-group.com\/de\/wp-json\/wp\/v2\/media?parent=3412"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}