{"id":5960,"date":"2026-07-07T08:09:51","date_gmt":"2026-07-07T08:09:51","guid":{"rendered":"https:\/\/globalpharmajobs.org\/?job_listing=ocugen-inc-hiring-for-icsr-submissions-specialist-pharmacovigilance"},"modified":"2026-07-07T08:09:51","modified_gmt":"2026-07-07T08:09:51","slug":"ocugen-inc-hiring-for-icsr-submissions-specialist-pharmacovigilance","status":"publish","type":"job_listing","link":"https:\/\/globalpharmajobs.org\/?job_listing=ocugen-inc-hiring-for-icsr-submissions-specialist-pharmacovigilance","title":{"rendered":"Ocugen Inc Hiring For ICSR Submissions Specialist (Pharmacovigilance)"},"content":{"rendered":"<p><br \/>\n<\/p>\n<div>\n<p class=\"wp-block-paragraph\">Ocugen Inc is hiring an experienced <strong>ICSR Submissions Specialist (Pharmacovigilance)<\/strong> for its Hyderabad location. This is an excellent opportunity for professionals with strong expertise in <strong>ICSR submissions, Argus Safety, and global pharmacovigilance compliance<\/strong> to work in a fast-growing biopharma environment.<\/p>\n<p class=\"wp-block-paragraph\">If you have hands-on experience in <strong>E2B(R2\/R3), FDA\/EMA submissions, and global safety reporting<\/strong>, this role offers career growth in international drug safety operations.<\/p>\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n<h3 class=\"wp-block-heading\">\ud83d\udccc Job Details<\/h3>\n<ul class=\"wp-block-list\">\n<li><strong>Role:<\/strong> ICSR Submissions Specialist (Pharmacovigilance)<\/li>\n<li><strong>Location:<\/strong> Hyderabad, Telangana, India<\/li>\n<li><strong>Job Type:<\/strong> Full-time, On-site<\/li>\n<li><strong>Experience:<\/strong> 5+ Years (3+ years in ICSR submissions)<\/li>\n<li><strong>Department:<\/strong> Drug Safety \/ Pharmacovigilance<\/li>\n<\/ul>\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n<h3 class=\"wp-block-heading\">\ud83e\udde9 Key Responsibilities<\/h3>\n<ul class=\"wp-block-list\">\n<li>Manage <strong>end-to-end ICSR submissions<\/strong> to global regulatory authorities (FDA, EMA, MHRA, PMDA, Health Canada)<\/li>\n<li>Ensure timely submission of <strong>expedited (7-day\/15-day) and periodic safety reports<\/strong><\/li>\n<li>Perform <strong>E2B (R2\/R3) electronic submissions<\/strong> via regulatory gateways<\/li>\n<li>Monitor acknowledgements and resolve <strong>submission failures or technical issues<\/strong><\/li>\n<li>Conduct <strong>quality checks on ICSRs<\/strong> for completeness and regulatory compliance<\/li>\n<li>Collaborate with <strong>Case Processing, QA, IT, and Regulatory Affairs teams<\/strong><\/li>\n<li>Maintain <strong>submission logs, reconciliation records, and audit-ready documentation<\/strong><\/li>\n<li>Support <strong>inspections, audits, and health authority queries<\/strong><\/li>\n<li>Ensure compliance with <strong>ICH E2B, E2A, GVP, and 21 CFR regulations<\/strong><\/li>\n<li>Drive <strong>process improvements and automation<\/strong> in safety reporting<\/li>\n<li>Train junior team members on <strong>ICSR submission processes and systems<\/strong><\/li>\n<\/ul>\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n<h3 class=\"wp-block-heading\">\ud83c\udf93 Qualifications &amp; Skills<\/h3>\n<ul class=\"wp-block-list\">\n<li><strong>Education:<\/strong> B.Pharm \/ M.Pharm \/ PharmD \/ Life Sciences \/ Medicine<\/li>\n<li><strong>Experience:<\/strong>\n<ul class=\"wp-block-list\">\n<li>Minimum <strong>5 years in Pharmacovigilance<\/strong><\/li>\n<li>At least <strong>3 years in ICSR submissions<\/strong><\/li>\n<\/ul>\n<\/li>\n<li><strong>Technical Skills:<\/strong>\n<ul class=\"wp-block-list\">\n<li>Strong knowledge of <strong>ICH E2B (R2\/R3)<\/strong><\/li>\n<li>Hands-on experience with <strong>Argus Safety (mandatory)<\/strong><\/li>\n<li>Experience with <strong>global regulatory submissions (US, EU, ROW)<\/strong><\/li>\n<li>Exposure to <strong>signal management &amp; aggregate reporting<\/strong><\/li>\n<\/ul>\n<\/li>\n<li><strong>Other Requirements:<\/strong>\n<ul class=\"wp-block-list\">\n<li>Experience in <strong>CRO\/pharmaceutical industry<\/strong><\/li>\n<li>Knowledge of <strong>partner safety data exchange agreements<\/strong><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n<h3 class=\"wp-block-heading\">\ud83d\udcbc Benefits<\/h3>\n<ul class=\"wp-block-list\">\n<li>Opportunity to work with a <strong>global biopharmaceutical company<\/strong><\/li>\n<li>Exposure to <strong>international pharmacovigilance systems and regulations<\/strong><\/li>\n<li>Career growth in <strong>drug safety and regulatory compliance<\/strong><\/li>\n<li>Collaborative work environment with cross-functional teams<\/li>\n<li>Competitive salary and performance-driven culture<\/li>\n<\/ul>\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n<h3 class=\"wp-block-heading\">\ud83d\udce9 How to Apply<\/h3>\n<p class=\"wp-block-paragraph\"><strong><a rel=\"nofollow\" target=\"_blank\" href=\"https:\/\/www.linkedin.com\/jobs\/view\/4403945408\/\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">Application Link<\/a><\/strong><\/p>\n<\/div>\n<p><br \/>\n<br \/><a href=\"https:\/\/pharmabharat.org\/ocugen-inc-hiring-for-icsr-submissions-specialist-pharmacovigilance\/\">Source link <\/a><\/p>\n","protected":false},"author":1,"featured_media":5961,"template":"","meta":{"_promoted":"","_job_location":"","_application":"","_company_name":"","_company_website":"","_company_tagline":"","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job_listing_region":[],"job-categories":[165],"job-types":[],"job_listing_tag":[],"class_list":["post-5960","job_listing","type-job_listing","status-publish","has-post-thumbnail","hentry","job_listing_category-pharmacovigilance"],"_links":{"self":[{"href":"https:\/\/globalpharmajobs.org\/index.php?rest_route=\/wp\/v2\/job-listings\/5960","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/globalpharmajobs.org\/index.php?rest_route=\/wp\/v2\/job-listings"}],"about":[{"href":"https:\/\/globalpharmajobs.org\/index.php?rest_route=\/wp\/v2\/types\/job_listing"}],"author":[{"embeddable":true,"href":"https:\/\/globalpharmajobs.org\/index.php?rest_route=\/wp\/v2\/users\/1"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/globalpharmajobs.org\/index.php?rest_route=\/wp\/v2\/media\/5961"}],"wp:attachment":[{"href":"https:\/\/globalpharmajobs.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=5960"}],"wp:term":[{"taxonomy":"job_listing_region","embeddable":true,"href":"https:\/\/globalpharmajobs.org\/index.php?rest_route=%2Fwp%2Fv2%2Fjob_listing_region&post=5960"},{"taxonomy":"job_listing_category","embeddable":true,"href":"https:\/\/globalpharmajobs.org\/index.php?rest_route=%2Fwp%2Fv2%2Fjob-categories&post=5960"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/globalpharmajobs.org\/index.php?rest_route=%2Fwp%2Fv2%2Fjob-types&post=5960"},{"taxonomy":"job_listing_tag","embeddable":true,"href":"https:\/\/globalpharmajobs.org\/index.php?rest_route=%2Fwp%2Fv2%2Fjob_listing_tag&post=5960"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}