ICSR Reporting and Compliance Manager

About Alkem

Alkem Laboratories Limited is an Indian multinational pharmaceutical company headquartered in Mumbai, that manufactures and sells pharmaceutical generics, formulations and nutraceuticals in India and globally over 50 countries. We have consistently been ranked amongst the top five pharmaceutical companies in India. Our portfolio includes illustrious brands like Clavam, Pan, Pan-D, and Taxim-O, which feature amongst the top 50 pharmaceutical brands in India.

Essential Duties and Responsibilities :

• Case Validation & Quality : Validate the quality and reporting criteria of case reports prior to submission to ensure accuracy and completeness.
• ICSR Submission Execution : Execute the daily generation and submission of ICSRs to global health authorities (e.G., US FDA, EMA), ensuring strict adherence to reporting timelines.
• Manual Submissions Management : Manage and execute manual submissions (e.G., via email) for non-gateway regulatory agencies (e.G., PvPI-CDSCO, TGA).
• Regulatory Compliance : Maintain and adhere to all Expedited Reporting Rules and accurately manage the Submission Clock to ensure zero regulatory deviations.
• Reconciliation & Integrity : Perform daily reconciliation within the safety database to ensure 100% submission compliance and data integrity.
• Technical Troubleshooting : Act as the primary troubleshooter for transmission failures, Negative Acknowledgements (NACKs), and E2B XML errors, collaborating with vendors for resolution.
• Gateway & System Maintenance : Actively monitor Electronic Submission Gateways for certificate validity and connectivity, and resolve "stuck" cases or re-submission issues.
• Regulatory Updates & Implementation : Implement updates related to changes in XML schemas (e.G., E2B R3) and other regional regulatory requirements (e.G., GDPR).
• Partner Submissions : Manage automated or manual ICSR submission to licensing partners in accordance with Safety Data Exchange Agreements (SDEAs).
• Audit Readiness & BCP : Maintain "Audit Ready" submission logs and trigger Business Continuity Plans (BCP) during system failures to sustain compliance.

Education background : B.Pharm / M.Pharm / M.Sc.

Preferred Experience : 4-6 years in ICSR case processing & 2-3 years in ICSR submission