Are you passionate about pharmaceutical safety and regulatory compliance? Alkem Laboratories Ltd, a leading Indian multinational pharmaceutical company headquartered in Mumbai, is seeking a dedicated ICSR Submission Specialist to join their team. With a strong presence in over 50 countries and top-ranked brands like Clavam and Pan-D, Alkem offers a dynamic environment for professionals in pharma ICSR submission jobs in India. This on-site, full-time role in Mumbai, Maharashtra, focuses on managing Individual Case Safety Reports (ICSRs) to global health authorities, ensuring accuracy and timeliness in a fast-paced pharmaceutical setting.
As an ICSR Submission Specialist, you’ll play a crucial role in maintaining compliance with regulations from bodies like the US FDA and EMA, while contributing to Alkem’s commitment to patient safety and innovative generics. If you have experience in ICSR case processing and submission, this position could be your gateway to advancing in the pharmaceutical industry.
Key Responsibilities
In this pharma ICSR specialist role, you’ll handle critical tasks to uphold regulatory standards:
- Case Validation & Quality: Validate ICSR reports for accuracy and completeness before submission.
- ICSR Submission Execution: Generate and submit daily ICSRs to global authorities like US FDA and EMA, adhering to strict timelines.
- Manual Submissions Management: Execute manual submissions via email to agencies such as PvPI-CDSCO and TGA.
- Regulatory Compliance: Follow Expedited Reporting Rules and manage the Submission Clock to avoid deviations.
- Reconciliation & Integrity: Perform daily database reconciliations for 100% compliance and data integrity.
- Technical Troubleshooting: Troubleshoot transmission failures, NACKs, and E2B XML errors, collaborating with vendors.
- Gateway & System Maintenance: Monitor Electronic Submission Gateways for connectivity and resolve submission issues.
- Regulatory Updates & Implementation: Implement changes in XML schemas (e.g., E2B R3) and regional requirements like GDPR.
- Partner Submissions: Manage ICSR submissions to licensing partners per Safety Data Exchange Agreements (SDEAs).
- Audit Readiness & BCP: Maintain audit-ready logs and activate Business Continuity Plans during system failures.
Qualifications
To excel in this ICSR submission jobs in India, candidates should possess:
- Education: B.Pharm, M.Pharm, or M.Sc. in a relevant field.
- Experience: 4-6 years in ICSR case processing, with 2-3 years specifically in ICSR submission.
- Strong knowledge of pharmaceutical regulations, safety databases, and submission tools is essential for this pharma ICSR specialist role.
Benefits
Alkem Laboratories Ltd offers competitive compensation and a supportive work environment for its ICSR Submission Specialists:
- Competitive salary in the range of INR 500,000 to 800,000 annually, based on experience.
- Opportunities for professional growth and skill development in a top pharmaceutical company.
- Comprehensive benefits package, including health insurance, paid leave, and performance incentives.
- Work in a collaborative team at the heart of Mumbai’s pharma hub, contributing to global health initiatives.
How to Apply
Ready to apply for this ICSR Submission Specialist position at Alkem Laboratories Ltd? Use the Easy Apply feature on the job platform. Submit your resume highlighting your experience in pharma ICSR submission jobs in India, and stand out by showcasing your regulatory compliance expertise. Applications are open now—don’t miss this chance to join a leading pharmaceutical company in Mumbai, Maharashtra.