Vigilance Dashboard

Vigilance dashboard has been introduced to create and manage vigilance reports and regulatory inquiries for Australia and New Zealand markets.

To access vigilance dashboard:

  • Click on PMS/Vigilance Dashboard in the left navigation.
  • Clicking on PMS/Vigilance Dashboard will open vigilance page.

Figure: Vigilance Dashboard

 

To create a vigilance record:

  • Click on “Add Vigilance Record” button
  • Enter the details as per the pop up and click on “Next”.
  • Fill the details and “Submit”.

Figure: Add Vigilance Record

To add a child record:

  • Click on the 3 dots menu and select “Add Child Record”
  • Enter the details, select the child record to be created and click on “Submit”.

Figure: Add Child Record

 

 

To submit evidence:

  • Click on the 3 dots menu and select “View/Submit Evidence”.
  • Upload file and click on “Submit Evidence”.

Figure to View/Submit Evidence

To generate report:

  • Click on the 3 dots menu and select “Generate Report” Note: Report generation option is available only for Incident/Adverse event, initial, follow up and final/combined records
  • A report will be generated and downloaded in PDF format.

 

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PMS Dashboard

PMS dashboard has been introduced to efficiently submit and manage PMSR/PSUR reports to Emergo for EU, Switzerland and UK markets.

To access PMS Dashboard

  • In the vigilance dashboard page, enable "PMS" toggle on the top right corner.

Figure: Access PMS Dashboard

Figure: PMS Dashboard

To create PMS Record

  • Up on enabling PMS toggle, PMS dashboard page will be displayed
  • Click on "Add PMS Record"
  • Enter Client details, PMS type etc and click on "Submit".
  • The created record will be displayed in the PMS dashboard. 

Figure: Add PMS Record