Pharmacovigilance requires to achieve global coverage and meet diverse local market-specific regulatory frameworks. In this context, Marketing Authorization Holders must ensure a proper affiliate pharmacovigilance function across different countries, as well as they must ensure that their local PV network and governance system in place are robust enough to ensure comprehensive oversight and compliance on a global level.

Insuvia provides an end-to-end local PV outsourcing solution helping Marketing Authorization Holders establish state-of-the-art local PV processes under our Unified Governance Model throughout all countries of our presence.

Insuvia provides these local pharmacovigilance outsourcing solutions:

  • Provision of Local Qualified Persons for Pharmacovigilance (LPPV / Local QPPV) and Deputies 

  • Local medical and scientific literature screening 

  • Creation and maintenance of local PV systems, including local PSMF, local SOPs, etc. 

  • Assurance of 24/7 availability

  • Local PV legislation monitoring

  • Continuous monitoring and management of customer’s local safety mailboxes 

  • Handling of safety reports – intake, processing, reporting, tracking 

  • Submission of domestic and foreign ICSRs to local Competent Authorities 

  • Medical information inquiries handling in local languages 

  • Submission of aggregate safety reports (PSURs) and Risk Management Plans (RMPs)  

  • Local support with Risk Minimisation Measures (Educational Materials, DHPC communications) 

  • Handling of requests and inspections from local Competent Authorities 

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