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Modernising PV Generis
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Modernising PV

Automating pharmacovigilance with a modern cloud solution 

Pharmacovigilance Case Management

PV cases can be created in CARA from a number of input sources (XML input, emails, manual entry), and then processed to closure, including submission to the NCA using the ICH E2B R2/R3 standard

Intake Processing

Case Management



Case Intake

Information can come into the CARA case intake from a variety of sources (including emails, XML files, API from another system, manual entry etc), and will create a case.  Depending on the case information, notifications will be sent to the responsible parties based on the country / product or other criteria.  Additionally, CARA can create a data item / case in third party systems (e.g. SAP) or within e.g. Complaints on the CARA Life Science Platform

Case Processing

Cases can be automatically assigned to processors based on market, product, language, severity or any other criteria that you need.  As the case moves through its lifecycle, additional fields will become visible and/or mandatory, but for Data Privacy reasons some fields might be hidden from global processing teams and only available for the in-country teams

Case Reporting

Once cases are ready to be reported, CARA can generate the required XML files using ICH E2B R3 format for submission to the National Competence Authorities.  The submission to the gateway and managing the responses is coming in Q3 2021.


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