{"id":4716,"date":"2014-06-24T12:19:17","date_gmt":"2014-06-24T12:19:17","guid":{"rendered":"https:\/\/demo4.om-associates.in\/?post_type=dt_courses&#038;p=4716"},"modified":"2023-06-17T06:16:27","modified_gmt":"2023-06-17T06:16:27","slug":"drug-safety-and-pharmacovigilance","status":"publish","type":"dt_courses","link":"https:\/\/medipharmsolutions.com\/courses\/drug-safety-and-pharmacovigilance\/","title":{"rendered":"Advanced Drug Safety and Pharmacovigilance"},"content":{"rendered":"<div class=\"wpb-content-wrapper\">[vc_row][vc_column width=\"2\/3\"][vc_single_image image=\"7263\" img_size=\"full\"][vc_custom_heading text=\"Introduction to Drug Safety and Pharmacovigilance\" font_container=\"tag:h4|font_size:23px|text_align:center|line_height:1.3em\" use_theme_fonts=\"yes\"][vc_separator color=\"blue\" border_width=\"4\" el_width=\"10\" css=\".vc_custom_1686721855229{margin-top: -10px !important;}\"][vc_column_text]\n<p style=\"font-size: 16px; line-height: 1.9em; text-align: justify;\">Pharmacovigilance, also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effectswithpharmaceuticalproducts.<\/p>\n<p style=\"font-size: 16px; line-height: 1.9em; text-align: justify;\">The activity that is most commonly associated with pharmacovigilance and which consumes a significant amount of resources for regulatory authorities, is that of adverse event reporting. Adverse event (AE) reporting involves the receipt, triage, data entering, assessment, distribution, reporting (if appropriate), and archiving of AE data and documentation. The source of AE reports may include: spontaneous reports,solicited reports; reports from clinical or post-marketing studies; reports from literature sources; reports from the media and reports reported to drug regulatory authorities themselves. For pharmaceutical companies, AE reporting is a regulatory requirement in most countries. AE reporting also provides data to these companies and drug regulatory authorities that play a key role in assessing therisk-benefitprofileof agivendrug.<\/p>\n[\/vc_column_text][\/vc_column][vc_column width=\"1\/3\" css=\".vc_custom_1686645979011{border-top-width: 1px !important;border-right-width: 1px !important;border-bottom-width: 1px !important;border-left-width: 1px !important;background-color: #f9f9f9 !important;border-left-color: #da853d !important;border-left-style: double !important;border-right-color: #da853d !important;border-right-style: double !important;border-top-color: #da853d !important;border-top-style: double !important;border-bottom-color: #da853d !important;border-bottom-style: double !important;border-radius: 5px !important;}\"][vc_custom_heading text=\"Course Highlights\" font_container=\"tag:h4|font_size:23px|text_align:center|color:%23da853d|line_height:1.3em\" use_theme_fonts=\"yes\"][vc_separator color=\"blue\" border_width=\"4\" el_width=\"10\" css=\".vc_custom_1686304661773{margin-top: -20px !important;}\"][vc_column_text]\n<h6><i class=\"fa fa-check-square-o\" style=\"color: blue;\"><\/i> \u00a0 <strong>Modules - \u00a0 40<\/strong><\/h6>\n[\/vc_column_text][vc_column_text css=\".vc_custom_1686982422125{margin-top: 15px !important;}\"]\n<h6><i class=\"fa fa-check-square-o\" style=\"color: blue;\"><\/i> \u00a0 <strong>HRS of Learning- \u00a0 500+<\/strong><\/h6>\n[\/vc_column_text][vc_column_text css=\".vc_custom_1686982442331{margin-top: 15px !important;}\"]\n<h6><i class=\"fa fa-check-square-o\" style=\"color: blue;\"><\/i> \u00a0 <strong>Months - \u00a0 3<\/strong><\/h6>\n[\/vc_column_text][vc_column_text css=\".vc_custom_1686982468468{margin-top: 15px !important;}\"]\n<h6><i class=\"fa fa-check-square-o\" style=\"color: blue;\"><\/i> \u00a0 <strong>FAQs- \u00a0 450+<\/strong><\/h6>\n[\/vc_column_text][vc_column_text css=\".vc_custom_1686982497074{margin-top: 15px !important;}\"]\n<h6><i class=\"fa fa-check-square-o\" style=\"color: blue;\"><\/i> \u00a0 <strong>Mock Interview FAQs- \u00a0 150+<\/strong><\/h6>\n[\/vc_column_text][vc_empty_space height=\"10px\"][vc_empty_space][vc_column_text]\n<p style=\"text-align: center;\" id=\"nikbtnn\">\r\n\t<a class=\"paoc-popup-click paoc-popup-cust-7516 paoc-popup-simple_link paoc-popup-link\" href=\"javascript:void(0);\">Enroll Now<\/a>\r\n\r\n\n[\/vc_column_text][vc_empty_space][\/vc_column][\/vc_row][vc_row][vc_column][vc_empty_space][vc_row_inner][vc_column_inner][vc_custom_heading text=\"USP\" font_container=\"tag:h2|font_size:27px|text_align:center\" use_theme_fonts=\"yes\"][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner width=\"1\/3\" css=\".vc_custom_1686722426373{border-top-width: 1px !important;border-right-width: 1px !important;border-bottom-width: 1px !important;border-left-width: 1px !important;border-left-color: #dd9933 !important;border-left-style: dotted !important;border-right-color: #dd9933 !important;border-right-style: dotted !important;border-top-color: #dd9933 !important;border-top-style: dotted !important;border-bottom-color: #dd9933 !important;border-bottom-style: dotted !important;border-radius: 5px !important;}\"][vc_single_image image=\"6671\" img_size=\"full\" alignment=\"center\" css_animation=\"bounceInLeft\"][vc_column_text css=\".vc_custom_1686722951807{margin-top: -15px !important;}\"]\n<h4 style=\"color: #dd9933; text-align: center; line-height: 1.5em;\"><strong>Hands-on Advanced Drug Safety Training<\/strong><\/h4>\n<p style=\"text-align: center;\">from end to end case processing with narrative writing and MedDRA coding. <span style=\"visibility: hidden;\">bbkkfhgfhfhfhhfhfhfhfhfhbjbkjbkbkbbkbbkbjnk<\/span><\/p>\n[\/vc_column_text][\/vc_column_inner][vc_column_inner width=\"1\/3\" css=\".vc_custom_1686722528757{border-top-width: 1px !important;border-right-width: 1px !important;border-bottom-width: 1px !important;border-left-width: 1px !important;border-left-color: #dd9933 !important;border-left-style: dotted !important;border-right-color: #dd9933 !important;border-right-style: dotted !important;border-top-color: #dd9933 !important;border-top-style: dotted !important;border-bottom-color: #dd9933 !important;border-bottom-style: dotted !important;border-radius: 5px !important;}\"][vc_single_image image=\"6672\" img_size=\"full\" alignment=\"center\" css_animation=\"bounceInLeft\"][vc_column_text css=\".vc_custom_1686722898961{margin-top: -15px !important;}\"]\n<h4 style=\"color: #dd9933; text-align: center; line-height: 1.5em;\"><strong>Drug Safety Training Mentorship<span style=\"visibility: hidden;\"> dsaasdacsdscfcdsca<\/span><\/strong><\/h4>\n<p style=\"text-align: center;\">Most Impactful factor in your success is having subject matter experts as your career mentors. <span style=\"visibility: hidden;\">bbkkbjbkjbkbkbbkbbkbjnk<\/span><\/p>\n[\/vc_column_text][\/vc_column_inner][vc_column_inner width=\"1\/3\" css=\".vc_custom_1686722788918{border-top-width: 1px !important;border-right-width: 1px !important;border-bottom-width: 1px !important;border-left-width: 1px !important;border-left-color: #dd9933 !important;border-left-style: dotted !important;border-right-color: #dd9933 !important;border-right-style: dotted !important;border-top-color: #dd9933 !important;border-top-style: dotted !important;border-bottom-color: #dd9933 !important;border-bottom-style: dotted !important;border-radius: 5px !important;}\"][vc_single_image image=\"6668\" img_size=\"full\" alignment=\"center\" css_animation=\"bounceInLeft\"][vc_column_text css=\".vc_custom_1686722764567{margin-top: -15px !important;}\"]\n<h4 style=\"color: #dd9933; text-align: center; line-height: 1.5em;\"><strong>Best online Drug Safety Training Modules<\/strong><\/h4>\n<p style=\"text-align: center;\">which are crafted for current drug safety market needs, making our training course, the most sought after Drug Safety certification program.<\/p>\n[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner width=\"1\/3\" css=\".vc_custom_1686722426373{border-top-width: 1px !important;border-right-width: 1px !important;border-bottom-width: 1px !important;border-left-width: 1px !important;border-left-color: #dd9933 !important;border-left-style: dotted !important;border-right-color: #dd9933 !important;border-right-style: dotted !important;border-top-color: #dd9933 !important;border-top-style: dotted !important;border-bottom-color: #dd9933 !important;border-bottom-style: dotted !important;border-radius: 5px !important;}\"][vc_single_image image=\"6671\" img_size=\"full\" alignment=\"center\" css_animation=\"bounceInLeft\"][vc_column_text css=\".vc_custom_1686723063103{margin-top: -15px !important;}\"]\n<h4 style=\"color: #dd9933; text-align: center; line-height: 1.5em;\"><strong>Comprehensive Drug Safety Curriculum<\/strong><\/h4>\n<p style=\"text-align: center;\">For Drug Safety Associate training, with case processing, Aggregate reports such as PSUR\/PBRERs, Signal detection, and Risk Management.<\/p>\n[\/vc_column_text][\/vc_column_inner][vc_column_inner width=\"1\/3\" css=\".vc_custom_1686722528757{border-top-width: 1px !important;border-right-width: 1px !important;border-bottom-width: 1px !important;border-left-width: 1px !important;border-left-color: #dd9933 !important;border-left-style: dotted !important;border-right-color: #dd9933 !important;border-right-style: dotted !important;border-top-color: #dd9933 !important;border-top-style: dotted !important;border-bottom-color: #dd9933 !important;border-bottom-style: dotted !important;border-radius: 5px !important;}\"][vc_single_image image=\"6672\" img_size=\"full\" alignment=\"center\" css_animation=\"bounceInLeft\"][vc_column_text css=\".vc_custom_1686723114194{margin-top: -15px !important;}\"]\n<h4 style=\"color: #dd9933; text-align: center; line-height: 1.5em;\"><strong>Professional Certification in Drug Safety and Pharmacovigilance<\/strong><\/h4>\n<p style=\"text-align: center;\">Through our cutting edge rentention learning methods using LMS , we offer you the best Drug Safety training program.<\/p>\n[\/vc_column_text][\/vc_column_inner][vc_column_inner width=\"1\/3\" css=\".vc_custom_1686722788918{border-top-width: 1px !important;border-right-width: 1px !important;border-bottom-width: 1px !important;border-left-width: 1px !important;border-left-color: #dd9933 !important;border-left-style: dotted !important;border-right-color: #dd9933 !important;border-right-style: dotted !important;border-top-color: #dd9933 !important;border-top-style: dotted !important;border-bottom-color: #dd9933 !important;border-bottom-style: dotted !important;border-radius: 5px !important;}\"][vc_single_image image=\"6668\" img_size=\"full\" alignment=\"center\" css_animation=\"bounceInLeft\"][vc_column_text css=\".vc_custom_1686723226537{margin-top: -15px !important;}\"]\n<h4 style=\"color: #dd9933; text-align: center; line-height: 1.5em;\"><strong>Drug Safety Collaborations <span style=\"visibility: hidden;\">sakjdjkaskdkas<\/span><\/strong><\/h4>\n<p style=\"text-align: center;\">Leverage our network with our 100% Job placement <span style=\"visibility: hidden;\"> sdadasfasfasda asdfsdfasfas sdfdsfsdfsd sdfsdgdsg bdgdsgds sdfgsdgsg<\/span><\/p>\n[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_empty_space][vc_row_inner][vc_column_inner][vc_custom_heading text=\"Overview\" font_container=\"tag:h2|font_size:27px|text_align:center\" use_theme_fonts=\"yes\"][vc_empty_space][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row][vc_column][vc_tta_tabs][vc_tta_section title=\"Program Overview\" tab_id=\"1686715535329-5fdf0a5a-6309\"][vc_column_text]\n<p style=\"font-size: 16px; line-height: 1.9em; text-align: justify;\">The Advanced Drug Safety and Pharmacovigilance Certificate program is a very unique training program. The program provides a thorough understanding of the basic concepts of drug safety and risk management throughout the process of drug development and its life cycle in the open market either as a patent or generic drug. This exposure prepares students to understand and appreciate the various types and grades of Adverse Events.<\/p>\n<p style=\"font-size: 16px; line-height: 1.9em; text-align: justify;\">Students are trained to correlate the Adverse Event with any vital and systemic abnormality resulting from this and understand the causal relation of the drug known as Adverse Drug Reaction (ADR). This further builds the analytical skills needed to differentiate between the progress of the disease and ADR as a signal. This program will focus on the regulatory issues across global governmental agencies like the FDA, EMA, ICH, and others that improve safety.<\/p>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=\"Objectives\" tab_id=\"1686715535329-cbf52899-91cf\"][vc_column_text]\n<ul style=\"font-size: 16px; line-height: 1.9em;\">\n<li>Understand the FDA, EU-EMA, and ICH regulations for drug safety and pharmacovigilance.<\/li>\n<li>Develop advanced knowledge of the roles and responsibilities of various functionaries in Drug Safety departments, such as the Drug Safety Physician, Drug Safety Data Analyst, Drug Safety Associate or specialist, Drug Safety Data Entry Associate, Drug Safety Triage Officer, Drug Safety Scientist, Drug Safety Regulatory Associate, and etc.<\/li>\n<li>Practice the processes of triage, data entry, medical review, as well as reporting through the Oracle\u00ae Argus software.<\/li>\n<li>Detailed training in MedDRA coding and medical narrative writing for SAE reports.<\/li>\n<li>Expertise in narrative writing for various regulatory requirements.<\/li>\n<li>Capability for conducting end to end ICSR case management.<\/li>\n<li>Evolve and implement problem solving practices.<\/li>\n<li>Competency to handle pharmacovigilance audits.<\/li>\n<li>Working experience in Oracle Argus Software.<\/li>\n<li>Soft Skills development for interview success<\/li>\n<\/ul>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=\"Curriculam\" tab_id=\"1686715627012-fb5d841b-ec02\"][vc_column_text]\n<ul style=\"font-size: 16px;\">\n<li>History and Why Pharmacovigilance<\/li>\n<li>Drug Development process<\/li>\n<li>ICH -GCP guidelines \u2013 PV perspective<\/li>\n<li>Oracle Argus suite training<\/li>\n<li>Adverse Drug Reactions (ADRs)<\/li>\n<li>ICSR \u2013 Work flow states and timelines<\/li>\n<li>Serious Adverse events (SAEs) &amp; SUSARs<\/li>\n<li>MedDRA<\/li>\n<li>Drug coding<\/li>\n<li>Labelling Assessment<\/li>\n<li>Causality Assessment<\/li>\n<li>Narrative writing<\/li>\n<li>Query generation<\/li>\n<li>Follow up assessment<\/li>\n<li>Report generation and submission<\/li>\n<li>AOSE \u2013 Analysis of Similar events<\/li>\n<li>Reporting timelines<\/li>\n<li>Regulations and regulatory Databases<\/li>\n<li>Structure of Drug Safety department and cross functional teams.<\/li>\n<li>SOPS and working guidance in PV<\/li>\n<li>Medical devices<\/li>\n<li>Target medical events<\/li>\n<li>Vendor management<\/li>\n<li>Audits and Inspection<\/li>\n<li>Product quality complaints<\/li>\n<li>FAQs \u2013 Interview process<\/li>\n<li>Recent Updates to Drug Safety<\/li>\n<li>Future trends in Drug Safety<\/li>\n<\/ul>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=\"Duration\" tab_id=\"1686715679535-337208cf-5e8b\"][vc_column_text]\n<ul style=\"font-size: 16px;\">\n<li>Duration : 12 weeks<\/li>\n<li>Live webinars \u2013 twice weekly \u2013 60 min each.<\/li>\n<li>50 Self Paced online LMS Modules.<\/li>\n<li>500 Hours of learning material \u2013 videos\/ppts\/assignments.<\/li>\n<li>Updated as per ICH\/FDA guidelines.<\/li>\n<li>Recommended books provided.<\/li>\n<li>Hands-on Argus Safety database operation.<\/li>\n<li>Certification upon successful completion.<\/li>\n<\/ul>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=\"Career Paths\" tab_id=\"1686715731356-cf1a2141-a4a6\"][vc_column_text]\n<p style=\"font-size: 16px; line-height: 1.8em;\"><strong>Drug Safety Associate -<\/strong> MediPharm Solutions, the best Drug Safety Associate training institute in USA, offers 100% job placement assistance.<\/p>\n<p style=\"font-size: 16px; line-height: 1.8em;\"><strong>Case Processor-<\/strong> This certification training for Drug safety Associate offers one on one mentoring access with the top minds with vast experience in Drug Safety.<\/p>\n<p style=\"font-size: 16px; line-height: 1.8em;\"><strong>Drug Safety physician -<\/strong> Our Drug Safety Associate online courses cover all current industry standard topics, needed to make you job ready.<\/p>\n<p style=\"font-size: 16px; line-height: 1.8em;\"><strong>Medical Director-<\/strong> Get a professional certification in Drug Safety Associate from us , which is prepared by the industry experts in Drug Safety and Pharmacovigilance.<\/p>\n<p style=\"font-size: 16px; line-height: 1.8em;\"><strong>Safety specialist -<\/strong> If you are looking to start a Drug Safety Associate career, apply for the best Drug Safety Associate training in USA through our Advanced Drug Safety and Pharmacovigilance certificate program.<\/p>\n<p style=\"font-size: 16px; line-height: 1.8em;\">Safety lead<\/p>\n[\/vc_column_text][\/vc_tta_section][\/vc_tta_tabs][\/vc_column][\/vc_row]\n<\/div>","protected":false},"excerpt":{"rendered":"<p>.<\/p>\n","protected":false},"author":1,"featured_media":4482,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","class_list":["post-4716","dt_courses","type-dt_courses","status-publish","has-post-thumbnail","hentry","course_category-education"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.5 (Yoast SEO v22.7) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Advanced Drug Safety and Pharmacovigilance - Drug Safety and Pharmacovigilance Course<\/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:\/\/medipharmsolutions.com\/courses\/drug-safety-and-pharmacovigilance\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" 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