ICSR Submission Specialist

2 days ago


Mumbai, Maharashtra, India Alkem Laboratories Ltd. Full time ₹ 12,00,000 - ₹ 24,00,000 per year

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:

  1. Case Validation & Quality: Validate the quality and reporting criteria of case reports prior to submission to ensure accuracy and completeness.
  2. 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.
  3. Manual Submissions Management: Manage and execute manual submissions (e.g., via email) for non-gateway regulatory agencies (e.g., PvPI-CDSCO, TGA).
  4. Regulatory Compliance: Maintain and adhere to all Expedited Reporting Rules and accurately manage the Submission Clock to ensure zero regulatory deviations.
  5. Reconciliation & Integrity: Perform daily reconciliation within the safety database to ensure 100% submission compliance and data integrity.
  6. Technical Troubleshooting: Act as the primary troubleshooter for transmission failures, Negative Acknowledgements (NACKs), and E2B XML errors, collaborating with vendors for resolution.
  7. Gateway & System Maintenance: Actively monitor Electronic Submission Gateways for certificate validity and connectivity, and resolve "stuck" cases or re-submission issues.
  8. Regulatory Updates & Implementation: Implement updates related to changes in XML schemas (e.g., E2B R3) and other regional regulatory requirements (e.g., GDPR).
  9. Partner Submissions: Manage automated or manual ICSR submission to licensing partners in accordance with Safety Data Exchange Agreements (SDEAs).
  10. 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



  • Mumbai, Maharashtra, India d-00a5-4115-9f6f-d240815a28b6 Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    Company DescriptionCEBEX STEEL INDIA, an ISO 9001:2008 certified company, is a leading supplier, authorized dealer, stockholder, manufacturer, and exporter of high-quality metal alloys and products. With a diverse product portfolio including stainless steel, nickel alloys, titanium alloys, and duplex alloys, the company caters to various industries in India...

  • GRC Specialist

    6 days ago


    Mumbai, Maharashtra, India L&T Technology Services Ltd. Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    LTTS IndiaMumbaiJob DescriptionJob Description: Audit & Assurance Specialist (Security Audit) / GRC Specialist - 1 PositionRole Overview:As an Audit & Assurance Specialist, you will be responsible for ensuring the security and compliance of our systems, processes, and applications. Your primary focus will be on conducting comprehensive security audits,...

  • GRC Specialist

    4 days ago


    Mumbai, Maharashtra, India UST Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    3 - 5 Years1 OpeningMumbaiRole descriptionWe are seeking an Information Security GRC Specialist with 5-8 years of experience in Governance, Risk, and Compliance (GRC) within the NBFC sector. The ideal candidate will have strong knowledge of regulatory frameworks and guidelines, hands-on experience in compliance management, and excellent skills in reporting,...


  • Mumbai, Maharashtra, India Win in Life Academy Full time ₹ 8,00,000 - ₹ 12,00,000 per year

    The role will involve expertise in D & C Act and Rules as well as FSSAI regulations withexperience in FDA related activities. This profile will ensure timely and robust functional/crossfunctional coordination (R&D, QC, Marketing, Legal, Production, etc.), transparent executionand implementation of regulatory affairs and safety processes.Local Regulatory...

  • Sales Specialist

    2 days ago


    Mumbai, Maharashtra, India DroneStark Technologies Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job Opening: Sales Specialist – Drone Sales (DroneStark Technologies)Location: MumbaiRole Type: Full-time | Field + OfficeExperience: 1–5 yearsIndustry: Drones, Robotics, Government & Enterprise SalesAbout DroneStarkDroneStark Technologies Pvt. Ltd. is a leading Indian drone manufacturer specialising in heavy-lift UAVs surveillance platforms and...


  • Mumbai, Maharashtra, India Castellan Real Estate Partners Full time US$ 60,000 - US$ 90,000 per year

    Position Title: Compliance Specialist Affordable Housing (LIHTC)Location: Remote (Based in India, supporting California projects)Work Schedule: Full-time | Must be available to work in Pacific Standard Time (PST) overlap hoursReports To: Compliance ManagerAbout the RoleWe are seeking a detail-oriented and experienced Compliance Specialist to support our...


  • Navi Mumbai, Maharashtra, India Lionbridge Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    We are hiring for Sourcing Specialist role.Interested candidates email resumes to Position Summary: Sourcing SpecialistTotal experience: 2+ yearsLocation: Airoli, Navi MumbaiLionbridge is hiring a Sourcing Specialist to support our high-volume international recruitment efforts. In this role, you will be responsible for sourcing and engaging talented...


  • Mumbai, Maharashtra, India Topgear Consultants Full time ₹ 40,00,000 - ₹ 80,00,000 per year

    We are hiringLocation : Bhandup west - MumbaiOnsiteJob Title: Accounts SpecialistJob SummaryWe are seeking a detail-oriented and proactive Accounts Specialist to manage day-to-day accounting operations, including GST return filing, accounts receivable management, e-invoicing, and financial record maintenance in Tally ERP. The ideal candidate should have...


  • Mumbai, Maharashtra, India Aegan Technologies Private Limited Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    Aegan Technologies Hiring: QARA + SaMD Specialist (Contract Role)Locations: Pune | Chennai | Bangalore | Mumbai | HyderabadJoin Within: 15 DaysAbout the Role:Aegan Technologies is looking for experienced QARA + SaMD (Software as a Medical Device) professionals for a contract-based opportunity. The ideal candidate will play a key role in ensuring regulatory...


  • Mumbai, Maharashtra, India Amazon Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    Job summaryThe primary objective of the SLP Specialist is to provide security services, investigation and asset protection in designated area of responsibility, assist in mitigating product loss, and maintain customer satisfaction in accordance with India Security and Loss Prevention guidelines and policies.The role is cross-functional and requires deep...