TATA 1MG Technologies Team Roles
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What is the primary responsibility of the Program Manager in ensuring the smooth implementation of the Program?

  • Conduct inward process of inventory in their systems
  • Monitor the operations and intervene wherever required
  • Coordinate with the team for AE reporting
  • Ensure all team members are YRR trained and undergone all Program related trainings (correct)

    • Who is responsible for receiving and making calls to patients to coordinate for assistance dispatches?

  • TATA 1MGHSPL
  • Customer Support Agents (correct)
  • Program Manager
  • Quality/Program Manager

    • What is the frequency of the monthly refresher training organized by the Program Manager?

  • Quarterly
  • Annually
  • Monthly (correct)
  • Weekly

    • What is the role of TATA 1MG HSPL in the delivery of Novopen 4?

    <p>All of the above</p> Signup and view all the answers

    What is the purpose of the AE reconciliation report prepared by the Program Manager?

    <p>To report adverse events to DSU</p> Signup and view all the answers

    Who is responsible for ensuring the Status of AEs reported in a timely manner?

    <p>Program Manager</p> Signup and view all the answers

    Where should the AE form be shared?

    <p><a href="mailto:[email protected]">[email protected]</a></p> Signup and view all the answers

    What is the timeline for submitting the AE form?

    <p>Within 1 working day but no later than 3 calendar days</p> Signup and view all the answers

    What is the purpose of the RCA?

    <p>To identify changes in systems and processes</p> Signup and view all the answers

    Who is responsible for collating incidents and presenting to the Client?

    <p>Quality department</p> Signup and view all the answers

    When do TATA 1mg and Novo Nordisk Drug Safety unit reconcile all the AEs reported?

    <p>In the first week of each month</p> Signup and view all the answers

    What is the format of the incident report?

    <p>As per Annexure 5</p> Signup and view all the answers

    Where are patient documents stored?

    <p>Program Google Folder</p> Signup and view all the answers

    How long are patient documents retained?

    <p>5 years from the date of receiving</p> Signup and view all the answers

    Who is responsible for periodically reviewing and updating this document?

    <p>QA/Program manager</p> Signup and view all the answers

    What is the primary purpose of the Safety Data Exchange Agreement?

    <p>To report adverse events</p> Signup and view all the answers

    What happens to patient documents after the retention period is complete?

    <p>They are deleted automatically</p> Signup and view all the answers

    What is the purpose of the CAPA process?

    <p>To ensure corrective and preventive actions</p> Signup and view all the answers

    What is the primary purpose of the AE/PC reporting process?

    <p>To report adverse events</p> Signup and view all the answers

    Where are call records stored?

    <p>AWS cloud system</p> Signup and view all the answers

    What is the purpose of the QC process?

    <p>To ensure quality control</p> Signup and view all the answers

    Who is responsible for updating the document history?

    <p>QA/Program manager</p> Signup and view all the answers

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