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?

All of the above Signup and view all the answers

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

To report adverse events to DSU Signup and view all the answers

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

Program Manager Signup and view all the answers

Where should the AE form be shared?

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

What is the timeline for submitting the AE form?

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

What is the purpose of the RCA?

To identify changes in systems and processes Signup and view all the answers

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

Quality department Signup and view all the answers

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

In the first week of each month Signup and view all the answers

What is the format of the incident report?

As per Annexure 5 Signup and view all the answers

Where are patient documents stored?

Program Google Folder Signup and view all the answers

How long are patient documents retained?

5 years from the date of receiving Signup and view all the answers

Who is responsible for periodically reviewing and updating this document?

QA/Program manager Signup and view all the answers

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

To report adverse events Signup and view all the answers

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

They are deleted automatically Signup and view all the answers

What is the purpose of the CAPA process?

To ensure corrective and preventive actions Signup and view all the answers

TATA 1MG Technologies Team Roles

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Questions and Answers

What is the primary responsibility of the Program Manager in ensuring the smooth implementation of the Program?

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

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

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

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

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

Where should the AE form be shared?

What is the timeline for submitting the AE form?

What is the purpose of the RCA?

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

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

What is the format of the incident report?

Where are patient documents stored?

How long are patient documents retained?

Who is responsible for periodically reviewing and updating this document?

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

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

What is the purpose of the CAPA process?

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

Where are call records stored?

What is the purpose of the QC process?

Who is responsible for updating the document history?

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