{"id":46,"date":"2025-06-27T06:21:05","date_gmt":"2025-06-27T06:21:05","guid":{"rendered":"https:\/\/pharmashok.in\/?p=46"},"modified":"2025-06-27T06:21:05","modified_gmt":"2025-06-27T06:21:05","slug":"job-opening-icsr-submission-expert-pharmacovigilance-department","status":"publish","type":"post","link":"https:\/\/pharmashok.in\/index.php\/2025\/06\/27\/job-opening-icsr-submission-expert-pharmacovigilance-department\/","title":{"rendered":"Job Opening: ICSR Submission Expert \u2013 Pharmacovigilance Department"},"content":{"rendered":"\n<p>Company: Macleods Pharmaceuticals Ltd.<\/p>\n\n\n\n<p>Department: Pharmacovigilance (ICSR Profile)<\/p>\n\n\n\n<p>Location: Andheri, Mumbai<\/p>\n\n\n\n<p>Number of Positions: 01Experience <\/p>\n\n\n\n<p>Required: 2 \u2013 4 years<\/p>\n\n\n\n<p>Employment Type: Full-Time<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\ud83d\udcdd Job Responsibilities:<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Submission of ICSR reports to regulatory bodies such as EMA, MHRA, USFDA, CDSCO (India), and RoW countries.<\/li>\n\n\n\n<li>Validate ARGUS fields influencing case submission (e.g. country of incidence, report type).<\/li>\n\n\n\n<li>Perform expectedness and listedness checks.<\/li>\n\n\n\n<li>Identify regulatory authorities, local operating companies, and license partners for reporting based on case specifics and PV agreements.<\/li>\n\n\n\n<li>Determine the report format (E2B or CIOMS) and submission timelines per applicable regulations.<\/li>\n\n\n\n<li>Submit reports manually via E2B or CIOMS through the global PV mailbox.<\/li>\n\n\n\n<li>Respond to regulatory queries on product safety issues for marketed products.<\/li>\n\n\n\n<li>Detect inconsistencies in ARGUS reports and coordinate changes for accurate reporting.<\/li>\n\n\n\n<li>Address internal and external queries related to case submissions.<\/li>\n\n\n\n<li>Conduct periodic reconciliation of reports (monthly\/quarterly).<\/li>\n\n\n\n<li>Maintain and monitor submission-related reporting rules.<\/li>\n\n\n\n<li>Coordinate with regulatory authorities as needed for submission activities.<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\ud83c\udf93 Minimum Qualification &amp; Skills:<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Educational Background:<\/strong> B.Pharm \/ M.Pharm \/ Pharm.D<\/li>\n\n\n\n<li><strong>Experience:<\/strong> 2\u20134 years in the Pharmacovigilance domain (ICSR processing and submission)<\/li>\n\n\n\n<li><strong>Key Skills:<\/strong>\n<ul class=\"wp-block-list\">\n<li>Strong verbal and written communication<\/li>\n\n\n\n<li>Knowledge of global PV regulations and PV databases<\/li>\n\n\n\n<li>Familiarity with ARGUS safety database and MedDRA coding<\/li>\n\n\n\n<li>Competence in evaluating ICSR seriousness, relatedness, expectedness<\/li>\n\n\n\n<li>Experience in handling medical device malfunction reports (preferred)<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\ud83d\udce7 <strong>Application Process:<\/strong><\/h3>\n\n\n\n<p>Interested and eligible candidates may send their updated CVs to:<br>\ud83d\udc49 <strong><a>adityab@macleodspharma.com<\/a><\/strong><\/p>\n\n\n\n<p><strong>Subject Line:<\/strong> <em>Application for ICSR Submission Expert \u2013 Pharmacovigilance Department<\/em><\/p>\n\n\n\n<p>You can share your article for Publication<\/p>\n\n\n\n<p>For More Join our&nbsp;<strong>Whatsapp Group<\/strong><\/p>\n\n\n\n<p><a href=\"https:\/\/chat.whatsapp.com\/BeuLhn7wpsu9M8hdvzoUIX\">https:\/\/chat.whatsapp.com\/BeuLhn7wpsu9M8hdvzoUIX<\/a><\/p>\n\n\n\n<p><strong>Note:<\/strong><br>Candidates who have applied for any of the above positions can avail&nbsp;<strong>free interview preparation support<\/strong>&nbsp;from our expert team.<\/p>\n\n\n\n<p>You can share your article for Publication<\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Company: Macleods Pharmaceuticals Ltd. Department: Pharmacovigilance (ICSR Profile) Location: Andheri, Mumbai Number of Positions: 01Experience Required: 2 \u2013 4 years&hellip;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-46","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/pharmashok.in\/index.php\/wp-json\/wp\/v2\/posts\/46","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmashok.in\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharmashok.in\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharmashok.in\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmashok.in\/index.php\/wp-json\/wp\/v2\/comments?post=46"}],"version-history":[{"count":1,"href":"https:\/\/pharmashok.in\/index.php\/wp-json\/wp\/v2\/posts\/46\/revisions"}],"predecessor-version":[{"id":47,"href":"https:\/\/pharmashok.in\/index.php\/wp-json\/wp\/v2\/posts\/46\/revisions\/47"}],"wp:attachment":[{"href":"https:\/\/pharmashok.in\/index.php\/wp-json\/wp\/v2\/media?parent=46"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmashok.in\/index.php\/wp-json\/wp\/v2\/categories?post=46"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmashok.in\/index.php\/wp-json\/wp\/v2\/tags?post=46"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}