{"id":70522,"date":"2016-03-15T13:59:22","date_gmt":"2016-03-15T13:59:22","guid":{"rendered":"http:\/\/fintech.commercegurus.com\/?page_id=70522"},"modified":"2017-03-10T19:06:34","modified_gmt":"2017-03-10T19:06:34","slug":"drug-safety-pharmacovigilance","status":"publish","type":"page","link":"https:\/\/wizardtechsolutions.com\/services\/drug-safety-pharmacovigilance\/","title":{"rendered":"DRUG SAFETY \/ PHARMACOVIGILANCE"},"content":{"rendered":"

[vc_row type=”container” css=”.vc_custom_1462284973588{margin-bottom: 15px !important;}”][vc_column][vc_column_text]Wizard offers a comprehensive range of medical and pharmacovigilance services essential for the conduct of clinical trials including study preparation, study conduct, medical coding, medical review and Drug Safety Officer (DSO)activities. Depending on the contractual obligations, the staff at Wizard may take over a part or the complete responsibility for any medical or safety-related issues.
\nThe medical affairs team is comprised of physicians and pharmacists with many years of medical and pharmacovigilance experience and detailed knowledge in various therapeutic areas. By this we ensure that key requirements within clinical trials are managed in line with regulatory demands. For pharmacovigilance this includes not only the expedited reporting of Suspected Unexpected Serious Adverse Reactions (SUSAR) but also the appropriate handling of Serious Adverse Events (SAE) and Unexpected Adverse Event Information. On demand Wizard can provide 24X7 backup to investigators during conduct of trials.<\/p>\n

[\/vc_column_text][\/vc_column][\/vc_row][vc_row type=”container” css=”.vc_custom_1462284973588{margin-bottom: 15px !important;}”][vc_column width=”1\/2″][vc_single_image image=”71977″ img_size=”full” onclick=”link_image” css=”.vc_custom_1489172621566{margin-top: 6px !important;margin-bottom: 40px !important;}”][\/vc_column][vc_column width=”1\/2″][vc_single_image image=”71976″ img_size=”full” onclick=”link_image” css=”.vc_custom_1489172576194{margin-top: 6px !important;margin-bottom: 40px !important;}”][\/vc_column][\/vc_row][vc_row type=”container” css=”.vc_custom_1463590379269{padding-top: 50px !important;}”][vc_column][vc_column_text]Wizard offers a comprehensive range of medical and pharmacovigilance services essential for the conduct of clinical trials including study preparation, study conduct, medical coding, medical review and Drug Safety Officer (DSO)activities. Depending on the contractual obligations, the staff at Wizard\u00a0may take over a part or the complete responsibility for any medical or safety-related issues.<\/p>\n

The medical affairs team is comprised of physicians and pharmacists with many years of medical and pharmacovigilance experience and detailed knowledge in various therapeutic areas. By this we ensure that key requirements within clinical trials are managed in line with regulatory demands. For pharmacovigilance this includes not only the expedited reporting of Suspected Unexpected Serious Adverse Reactions (SUSAR) but also the appropriate handling of Serious Adverse Events (SAE) and Unexpected Adverse Event Information. On demand Wizard can provide 24X7 backup to investigators during conduct of trials.[\/vc_column_text][vc_tta_accordion style=”flat” shape=”square” color=”white” gap=”5″ c_position=”right” active_section=”1″][vc_tta_section title=”DRUG SAFETY \/ PHARMACOVIGILANCE” tab_id=”1461933709328-c244378e-3536″][vc_column_text]<\/p>\n

    \n
  1. Data Collection & maintenance of global safety data<\/li>\n
  2. Safety medical monitoring of clinical trials<\/li>\n
  3. Protocol waiver and compliance assessment<\/li>\n
  4. Serious adverse events (SAEs) surveillance (24-hour coverage)<\/li>\n
  5. Serious adverse event processing<\/li>\n
  6. Lab data, imaging data, EKG and QTc, safety review<\/li>\n
  7. Medical coding of the cases<\/li>\n
  8. Medical review of the cases<\/li>\n
  9. Medical \/QA review<\/li>\n
  10. Drug Safety Monitoring Board (DSMB) management. Endpoint adjudication<\/li>\n
  11. Write DSMB charters and lead DSMBs meetings<\/li>\n
  12. Drug Safety \/ Pharmacovigilance operation planning and management<\/li>\n
  13. Signal Detection<\/li>\n
  14. Risk Management<\/li>\n<\/ol>\n

    [\/vc_column_text][\/vc_tta_section][vc_tta_section title=”Drug Safety Process” tab_id=”1461933709492-cef23462-3d62″][vc_column_text]<\/p>\n

      \n
    1. SAE\/AE Initial documentation and reporting<\/li>\n
    2. Case Report Characterization<\/li>\n
    3. Epidemiologic Perspective for Marketed Product Reports<\/li>\n
    4. Safety Data Management<\/li>\n
    5. AE and SAE tracking, coding<\/li>\n
    6. SAE case processing<\/li>\n
    7. MedDRA and WHO-DD coding, medical quality review<\/li>\n
    8. AE and SAE causality evaluations<\/li>\n
    9. SAE narrative composition<\/li>\n
    10. MedWatch (FDA 3500A)<\/li>\n
    11. CIOMS I forms<\/li>\n
    12. Preparation of Periodic Safety Update Reports (PSURs)<\/li>\n<\/ol>\n

      [\/vc_column_text][\/vc_tta_section][vc_tta_section title=”Advert Event Reporting And Regulatory Submissions” tab_id=”1461941837228-06d6075c-6806″][vc_column_text]<\/p>\n

        \n
      1. Electronic submissions to European authorities<\/li>\n
      2. US FDA<\/li>\n
      3. Canadian Health Authority<\/li>\n
      4. Achieving timeline targets<\/li>\n
      5. MHLW- Japanese Health Authority<\/li>\n
      6. DCGI- Indian Health Authority<\/li>\n
      7. Develop safety database<\/li>\n<\/ol>\n

        [\/vc_column_text][\/vc_tta_section][vc_tta_section title=”Safety Management For Pre-Authorization And Post-Marketing Services” tab_id=”1462106454848-cb462263-3225″][vc_column_text]<\/p>\n

          \n
        1. Call Center<\/li>\n
        2. Triaging<\/li>\n
        3. Case intake\/Data Entry<\/li>\n
        4. Safety narrative writing<\/li>\n
        5. Medical coding<\/li>\n
        6. Assessment of seriousness, causality, and expectedness<\/li>\n
        7. Medical Review<\/li>\n
        8. Regulatory reporting<\/li>\n
        9. Literature Search<\/li>\n
        10. Litigation Cases<\/li>\n
        11. Crisis Management<\/li>\n
        12. Signal Detection<\/li>\n
        13. Risk management<\/li>\n
        14. Aggregate Reporting<\/li>\n<\/ol>\n

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          [vc_row type=”container” css=”.vc_custom_1462284973588{margin-bottom: 15px !important;}”][vc_column][vc_column_text]Wizard offers a comprehensive range of medical and pharmacovigilance services essential for the conduct of clinical trials including study preparation, study conduct, medical coding, medical review and Drug Safety Officer (DSO)activities. Depending on the contractual obligations, the staff at Wizard may take over a part or the complete responsibility for any […]<\/p>\n","protected":false},"author":1,"featured_media":71818,"parent":8,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"acf":[],"yoast_head":"\nDRUG SAFETY \/ PHARMACOVIGILANCE - Wizard Tech Solutions<\/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:\/\/wizardtechsolutions.com\/services\/drug-safety-pharmacovigilance\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"DRUG SAFETY \/ PHARMACOVIGILANCE - Wizard Tech Solutions\" \/>\n<meta property=\"og:description\" content=\"[vc_row type=”container” css=”.vc_custom_1462284973588{margin-bottom: 15px !important;}”][vc_column][vc_column_text]Wizard offers a comprehensive range of medical and pharmacovigilance services essential for the conduct of clinical trials including study preparation, study conduct, medical coding, medical review and Drug Safety Officer (DSO)activities. Depending on the contractual obligations, the staff at Wizard may take over a part or the complete responsibility for any […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/wizardtechsolutions.com\/services\/drug-safety-pharmacovigilance\/\" \/>\n<meta property=\"og:site_name\" content=\"Wizard Tech Solutions\" \/>\n<meta property=\"article:modified_time\" content=\"2017-03-10T19:06:34+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/wizardtechsolutions.com\/wp-content\/uploads\/2016\/03\/economist-1650-1100.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1650\" \/>\n\t<meta property=\"og:image:height\" content=\"1100\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/wizardtechsolutions.com\/services\/drug-safety-pharmacovigilance\/\",\"url\":\"https:\/\/wizardtechsolutions.com\/services\/drug-safety-pharmacovigilance\/\",\"name\":\"DRUG SAFETY \/ PHARMACOVIGILANCE - Wizard Tech Solutions\",\"isPartOf\":{\"@id\":\"https:\/\/wizardtechsolutions.com\/#website\"},\"datePublished\":\"2016-03-15T13:59:22+00:00\",\"dateModified\":\"2017-03-10T19:06:34+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/wizardtechsolutions.com\/services\/drug-safety-pharmacovigilance\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/wizardtechsolutions.com\/services\/drug-safety-pharmacovigilance\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/wizardtechsolutions.com\/services\/drug-safety-pharmacovigilance\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/wizardtechsolutions.com\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Services\",\"item\":\"https:\/\/wizardtechsolutions.com\/services\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"DRUG SAFETY \/ PHARMACOVIGILANCE\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/wizardtechsolutions.com\/#website\",\"url\":\"https:\/\/wizardtechsolutions.com\/\",\"name\":\"Wizard Tech Solutions\",\"description\":\"Leading IT Service Providers\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/wizardtechsolutions.com\/?s={search_term_string}\"},\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"en-US\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"DRUG SAFETY \/ PHARMACOVIGILANCE - Wizard Tech Solutions","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:\/\/wizardtechsolutions.com\/services\/drug-safety-pharmacovigilance\/","og_locale":"en_US","og_type":"article","og_title":"DRUG SAFETY \/ PHARMACOVIGILANCE - Wizard Tech Solutions","og_description":"[vc_row type=”container” css=”.vc_custom_1462284973588{margin-bottom: 15px !important;}”][vc_column][vc_column_text]Wizard offers a comprehensive range of medical and pharmacovigilance services essential for the conduct of clinical trials including study preparation, study conduct, medical coding, medical review and Drug Safety Officer (DSO)activities. 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