ICSR Submission Specialist

You will be responsible for the following tasks in the role: - Validate the quality and reporting criteria of case reports before submission to ensure accuracy and completeness. - Execute the daily generation and submission of ICSRs to global health authorities (e.g., US FDA, EMA) while strictly adhering to reporting timelines. - Manage and execute manual submissions (e.g., via email) for non-gateway regulatory agencies (e.g., PvPI-CDSCO, TGA). - Maintain and adhere to all Expedited Reporting Rules and accurately manage the Submission Clock to ensure zero regulatory deviations. - Perform daily reconciliation within the safety database to ensure 100% submission compliance and data integrity. - Act as the primary troubleshooter for transmission failures, Negative Acknowledgements (NACKs), and E2B XML errors, collaborating with vendors for resolution. - Actively monitor Electronic Submission Gateways for certificate validity and connectivity, and resolve "stuck" cases or re-submission issues. - Implement updates related to changes in XML schemas (e.g., E2B R3) and other regional regulatory requirements (e.g., GDPR). - Manage automated or manual ICSR submission to licensing partners in accordance with Safety Data Exchange Agreements (SDEAs). - Maintain "Audit Ready" submission logs and trigger Business Continuity Plans (BCP) during system failures to sustain compliance. Qualifications required for this role include: - Education background: B.Pharm/M.Pharm/M.Sc. - Preferred Experience: 4-6 years in ICSR case processing & 2-3 years in ICSR submission Alkem Laboratories Limited is an Indian multinational pharmaceutical company headquartered in Mumbai. They manufacture and sell pharmaceutical generics, formulations, and nutraceuticals in India and globally to over 50 countries. Alkem has consistently been ranked amongst the top five pharmaceutical companies in India. Their portfolio includes renowned brands like Clavam, Pan, Pan-D, and Taxim-O, which are among the top 50 pharmaceutical brands in India.,