{"id":857,"date":"2022-02-15T14:40:23","date_gmt":"2022-02-15T17:40:23","guid":{"rendered":"https:\/\/ondawebhost4.com.br\/vita\/en\/?post_type=servicos&#038;p=857"},"modified":"2022-04-05T11:32:13","modified_gmt":"2022-04-05T14:32:13","slug":"pharmacovigilance","status":"publish","type":"servicos","link":"https:\/\/www.vitapharmaconsulting.com\/en\/servicos\/pharmacovigilance\/","title":{"rendered":"Pharmacovigilance:"},"content":{"rendered":"<ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Appointment of Qualified Person for Pharmacovigilance (QPPV).<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Appointment of a Medically Qualified Person (doctor) to support the QPPV.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Appointment of the contact person in Portugal for matters of pharmacovigilance 24\/7.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Tracking Periodic Security Reports \/ RPS submission calendar management.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Research and weekly submission of Adverse Drug Reactions (RAMs) in the international literature.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Weekly Adverse Drug Reactions (RAMs) survey in local literature.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Training in pharmacovigilance for current and new employees.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Supply and implementation\/adaptation of SOP\u2019s.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">ICSR (Individual Case Safety reports) management,including,treatment, causality analysis and transmission of expedited reports of RAMs by EudraVigilance system.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Preparation of the Risk Management Plan.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Elaboration of Pharmacovigilance System Master File and Summary of the PSMF<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Signal detection in pharmacovigilance, including review of EVDAS.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Signal validation procedure.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Support for post-authorization studies of safety and efficacy (PASS and PAES).<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Risk management systems.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Pharmacovigilance quality system.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Monitoring of risk minimization measures.<\/span><\/li>\n<\/ul>\n","protected":false},"featured_media":0,"template":"","meta":{"inline_featured_image":false,"_links_to":"","_links_to_target":""},"regioes":[6],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Pharmacovigilance: - Vita<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.vitapharmaconsulting.com\/en\/servicos\/pharmacovigilance\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharmacovigilance: - Vita\" \/>\n<meta property=\"og:description\" content=\"Appointment of Qualified Person for Pharmacovigilance (QPPV). 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Appointment of a Medically Qualified Person (doctor) to support the QPPV. Appointment of the contact person in Portugal for matters of pharmacovigilance 24\/7. Tracking Periodic Security Reports \/ RPS submission calendar management. Research and weekly submission of Adverse Drug Reactions (RAMs) in the international literature. Weekly Adverse Drug... 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