{"id":1706,"date":"2022-04-18T10:44:44","date_gmt":"2022-04-18T10:44:44","guid":{"rendered":"http:\/\/box5774.temp.domains\/~noymedco\/?page_id=1706"},"modified":"2024-10-24T14:39:32","modified_gmt":"2024-10-24T14:39:32","slug":"pharmacovigilance-3","status":"publish","type":"page","link":"https:\/\/www.noymed.com\/~noymedco\/pharmacovigilance-3\/","title":{"rendered":"Pharmacovigilance"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"1706\" class=\"elementor elementor-1706\" data-elementor-settings=\"{&quot;ha_cmc_init_switcher&quot;:&quot;no&quot;}\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-8a8c12e elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"8a8c12e\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5c9e4b8\" data-id=\"5c9e4b8\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-c1358fd elementor-section-full_width elementor-section-content-middle elementor-section-height-min-height elementor-section-height-default\" data-id=\"c1358fd\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-f1ea440\" data-id=\"f1ea440\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-9cc1be9\" data-id=\"9cc1be9\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-633d23b elementor-widget elementor-widget-heading\" data-id=\"633d23b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><br>PHARMACOVIGILANCE &amp; SAFETY MONITORING\u200b<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-42a8e77 elementor-widget elementor-widget-text-editor\" data-id=\"42a8e77\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>NoyMed\u2019s professional team of Pharmacovigilance specialists has 10+ years of expertise and valuable experience working with the biggest names in the pharmaceutical industry. Our team consists of highly experienced doctors and physicians covering diverse therapeutic areas such as oncology, hematology, transfusion medicine, gastroenterology, infectious diseases, traumatology, orthopedics, surgery, sexology, dentistry, radiology, pulmonology, cardiology, and more.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-7dee7b4 elementor-widget elementor-widget-heading\" data-id=\"7dee7b4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\"><br><br>PHARMACOVIGILANCE<br><br><\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-e59e7ef elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"e59e7ef\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-f918a25\" data-id=\"f918a25\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-fd48a73 elementor-widget elementor-widget-text-editor\" data-id=\"fd48a73\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>Individual Case Safety Reports (ICSR)<\/li><li>Safety Surveillance and Risk Management\/Signal Management Process<\/li><li>Aggregate Reports<\/li><li>Qualified Person for Pharmacovigilance (QPPV)<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3c89579 elementor-widget elementor-widget-heading\" data-id=\"3c89579\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">ICSR<br><\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f8ecead elementor-widget elementor-widget-text-editor\" data-id=\"f8ecead\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul>\n<li>Case intake<\/li>\n<li>Case triaging<\/li>\n<li>Case processing<\/li>\n<li>Events coding<\/li>\n<li>Quality control<\/li>\n<li>Medical review<\/li>\n<li>Submission to the regulatory bodies<\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-486419c elementor-widget elementor-widget-heading\" data-id=\"486419c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Safety Surveillance and Risk Management \n\/ Signal Management Process<br><\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6b4e50e elementor-widget elementor-widget-text-editor\" data-id=\"6b4e50e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>Monitoring global and local indexed and non-indexed journals, and data mining<\/li><li>Signal detection<\/li><li>Signal validation<\/li><li>Signal assessment and evaluation<\/li><li>Signal confirmation<\/li><li>Risk minimization measures: risk management plan\/risk evaluation and mitigation strategies<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b832c50 elementor-widget elementor-widget-heading\" data-id=\"b832c50\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Aggregate reports<br><\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8e08f67 elementor-widget elementor-widget-text-editor\" data-id=\"8e08f67\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>Periodic Safety Update Reports<\/li><li>Periodic Benefit Risk Evaluation Reports<\/li><li>Periodic Adverse Drug Experience Reports<\/li><li>Ad-hoc Reports and Health Authority Queries<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-63e102e elementor-widget elementor-widget-heading\" data-id=\"63e102e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">QPPV<br><\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-88f6664 elementor-widget elementor-widget-text-editor\" data-id=\"88f6664\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>Establishment and maintenance of the marketing authorization holder\u2019s pharmacovigilance system (PSMF)<\/li><li>Overview of drug safety profiles and emerging safety concerns<\/li><li>Awareness of conditions relating to safety of the products<\/li><li>Awareness of risk minimization measures<\/li><li>Review and sign-off of protocols of post-authorization safety studies<\/li><li>Submission of PV-related documents in accordance with the legal requirements<\/li><li>Ensuring a full response to request from the competent authorities (CA)<\/li><li>Providing input into the preparation of regulatory action in response to emerging safety concerns<\/li><li>Acting as a single PV contact point for the CA on a 24-hour basis and also as a contact point for PV inspections.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2509126 elementor-widget elementor-widget-heading\" data-id=\"2509126\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\"><br><br>SAFETY MONITORING<br><br><\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-976deff elementor-widget elementor-widget-text-editor\" data-id=\"976deff\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>Medical monitoring plan preparation<\/li><li>Medical support for investigator sites and project teams<\/li><li>Responding to subject eligibility and withdrawal questions<\/li><li>Medical review of Serious Adverse Events (SAE)<\/li><li>Assessment of SAE reports<\/li><li>Review of safety parameters and alert reports<\/li><li>Medical review of coding<\/li><li>Medical review of clinical study protocols and reports<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-62797dd4 elementor-section-content-middle elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"62797dd4\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-7c9805de\" data-id=\"7c9805de\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3d465fc6 elementor-widget elementor-widget-heading\" data-id=\"3d465fc6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Need our assistance?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-119622c8 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"119622c8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm elementor-animation-grow\" href=\"https:\/\/noymed.com\/~noymedco\/request-a-quote\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">CONTACT US<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5db803d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5db803d\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-89440f0\" data-id=\"89440f0\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>PHARMACOVIGILANCE &amp; SAFETY MONITORING&#8203; NoyMed&rsquo;s professional team of Pharmacovigilance specialists has 10+ years of expertise and valuable experience working with the biggest names in the pharmaceutical industry. Our team consists of highly experienced doctors and physicians covering diverse therapeutic areas such as oncology, hematology, transfusion medicine, gastroenterology, infectious diseases, traumatology, orthopedics, surgery, sexology, dentistry, radiology, [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":2411,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"nf_dc_page":"","content-type":"","om_disable_all_campaigns":false,"_uf_show_specific_survey":0,"_uf_disable_surveys":false,"footnotes":""},"class_list":["post-1706","page","type-page","status-publish","has-post-thumbnail","hentry"],"aioseo_notices":[],"jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/PbOYuo-rw","_links":{"self":[{"href":"https:\/\/www.noymed.com\/~noymedco\/wp-json\/wp\/v2\/pages\/1706","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.noymed.com\/~noymedco\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.noymed.com\/~noymedco\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.noymed.com\/~noymedco\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.noymed.com\/~noymedco\/wp-json\/wp\/v2\/comments?post=1706"}],"version-history":[{"count":5,"href":"https:\/\/www.noymed.com\/~noymedco\/wp-json\/wp\/v2\/pages\/1706\/revisions"}],"predecessor-version":[{"id":4303,"href":"https:\/\/www.noymed.com\/~noymedco\/wp-json\/wp\/v2\/pages\/1706\/revisions\/4303"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.noymed.com\/~noymedco\/wp-json\/wp\/v2\/media\/2411"}],"wp:attachment":[{"href":"https:\/\/www.noymed.com\/~noymedco\/wp-json\/wp\/v2\/media?parent=1706"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}