{"id":15890,"date":"2023-08-23T13:53:30","date_gmt":"2023-08-23T11:53:30","guid":{"rendered":"https:\/\/semmelweis.hu\/hok\/?p=15890"},"modified":"2023-09-17T16:41:48","modified_gmt":"2023-09-17T14:41:48","slug":"job-cpl-hungary-case-evaluator","status":"publish","type":"post","link":"https:\/\/semmelweis.hu\/hok\/en\/2023\/08\/23\/job-cpl-hungary-case-evaluator\/","title":{"rendered":"Job &#8211; CPL Hungary \/ Case Evaluator"},"content":{"rendered":"<p><strong>Scope of activities:<\/strong><br \/>\n&#8211; <a href=\"https:\/\/semmelweis.hu\/hok\/files\/2023\/08\/CaseEvaluator.pdf\">Case Evaluator<\/a><br \/>\n&#8211; Hybrid working, two days office: in Budapest, District XI and three days home office<br \/>\n&#8211; total working hours<\/p>\n<p>YOUR RESPONSIBILITIES WILL BE:<\/p>\n<ul>\n<li>Utilize clinical information in safety database to provide company causality assessment<br \/>\nand comment.<\/li>\n<li>Confirm determination of seriousness, assess drug product causal association, and assign<br \/>\nglobal labeling status (expected or unexpected) to achieve the appropriate case reporting<br \/>\nstatus for global distribution for regulatory agency reporting.<\/li>\n<li>Evaluate and assess complex reports from clinical development projects as well as postmarketing cases.<\/li>\n<li>Review case reports for medical accuracy, including validation of adverse event listedness<br \/>\nand coding consistency.<\/li>\n<li>Request follow-up information for robust case causality assessment.<\/li>\n<li>Adhere to global and local procedural documents.<\/li>\n<\/ul>\n<p>YOUR SKILLS AND QUALIFICATIONS:<\/p>\n<ul>\n<li>A Medical or Physician Degree.<\/li>\n<li>Good knowledge of US and EU pharmacovigilance regulatory requirements.<\/li>\n<li>Experience in pharmacovigilance practices concerning signal detection and evaluation is<br \/>\nan advantage.<\/li>\n<li>Knowledge of drug safety and clinical development and ICH\/GCP principles.<\/li>\n<li>The ability to evaluate, interpret and synthesize scientific data.<\/li>\n<li>The ability to present and critically discuss clinical data in both internal and external<br \/>\ndiscussions.<\/li>\n<li>User-level IT skills.<\/li>\n<\/ul>\n<p>SOME OF THE BENEFITS YOU WILL ENJOY:<\/p>\n<ul>\n<li>Hybrid working environment (3-day Home Office)<\/li>\n<li>We provide a wide range of benefits, including a market-leading comprehensive private<br \/>\nhealth care package.<\/li>\n<li>We offer extensive self-development opportunities: our colleagues have many training<br \/>\npossibilities for personal and professional growth.<\/li>\n<li>There are both vertical and horizontal career options for those who like to challenge<br \/>\nthemselves and try out different areas and positions.<\/li>\n<li>You will be part of a global and diverse working environment with relaxation areas,<br \/>\nterraces, and a friendly atmosphere.<\/li>\n<li>You can seize the day with us at our company events, hobby clubs, and sporting<br \/>\ninitiatives.<\/li>\n<\/ul>\n<p><strong>Employer:<\/strong><br \/>\n&#8211; CPL Hungary<br \/>\n&#8211; Budapest, District XI<br \/>\n&#8211; Nagy Andrea<br \/>\n&#8211;\u00a0<a href=\"mailto:andrea.nagy@cpl.com\" target=\"_blank\" rel=\"noopener\">andrea.nagy@cpl.com<\/a><br \/>\n&#8211; +36 70 477 1103<\/p>\n<p><strong>Targeted labour:<\/strong><br \/>\n\u2013 professional<br \/>\n\u2013 English (C1)<\/p>\n<p><strong>Fee:<\/strong><br \/>\nfixed salary<\/p>\n<p><strong>Required attachments:<\/strong><br \/>\nCV<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Scope of activities: &#8211; <a href=\"https:\/\/semmelweis.hu\/hok\/files\/2023\/08\/CaseEvaluator.pdf\">Case Evaluator<\/a> &#8211; Hybrid working, two days office: in Budapest, District XI and three days home office &#8211; total working hours YOUR RESPONSIBILITIES WILL BE: Utilize clinical information in safety database to provide company causality assessment and comment. Confirm determination of seriousness, assess drug product causal association, and assign global labeling status (expected &hellip;<\/p>\n","protected":false},"author":102250,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[769],"tags":[864,868,840,866],"class_list":["post-15890","post","type-post","status-publish","format-standard","hentry","category-archives","tag-fixed-salary","tag-hybrid-working","tag-professional","tag-total-working-hours"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"1970-01-01 01:00:00","action":"","terms":[],"taxonomy":"","browser_timezone_offset":0},"_links":{"self":[{"href":"https:\/\/semmelweis.hu\/hok\/wp-json\/wp\/v2\/posts\/15890","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/semmelweis.hu\/hok\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/semmelweis.hu\/hok\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/semmelweis.hu\/hok\/wp-json\/wp\/v2\/users\/102250"}],"replies":[{"embeddable":true,"href":"https:\/\/semmelweis.hu\/hok\/wp-json\/wp\/v2\/comments?post=15890"}],"version-history":[{"count":1,"href":"https:\/\/semmelweis.hu\/hok\/wp-json\/wp\/v2\/posts\/15890\/revisions"}],"predecessor-version":[{"id":15892,"href":"https:\/\/semmelweis.hu\/hok\/wp-json\/wp\/v2\/posts\/15890\/revisions\/15892"}],"wp:attachment":[{"href":"https:\/\/semmelweis.hu\/hok\/wp-json\/wp\/v2\/media?parent=15890"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/semmelweis.hu\/hok\/wp-json\/wp\/v2\/categories?post=15890"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/semmelweis.hu\/hok\/wp-json\/wp\/v2\/tags?post=15890"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}