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