ZEINCRO Pharmacovigilance and Safety Department Facts:

  • Existing since 2003 with mature quality and efficacy SOP system
  • End to end pre-approval (clinical safety) and post-approval PV and Device vigilance services

  • 2 Global Safety Hubs(highly cost-efficient European Safety Hubs in Sofia and Athens)

    • 5+ years’ experience of operational staff in Global Hubs
    • Clinical Safety Center of excellence within Global Hubs
    • Device vigilance Center of Excellence within Global Hubs
    • Safety Database: in-house ARISg (clients’ ARGUS)
    • High English Language proficiency - tested at hiring

    Local Safety Services– Local QP and Local Literature Review (48 countries)

    • 2+ years’ experience of staff engaged in Local QP and Local Literature Review
    • Traditional presence with permanent PV employees in local services
    • Seasoned management with background in International CROs and global pharma

    Staff turnover 2017– less than 10%

    IT: LARS - Proprietary PV Software for Local Literature Review in all European Languages including Turkey, Russia and Ukraine. Fully validated, audit trailed and compliant with the Code of Federal Regulations Title 21, Part 11

    Social Media scanning

    Zeincro PV is also entrusted with very specific PV projects. In 2017 Zeincro started scanning Tweeter for Adverse Events for a global pharma company.

    Regulatory Consultancy in PV – Zeincro has been a service provider to Cortellis (former IDRAC Reuters commercial Regulatory Database for pharma) for PV/ DV and Regulatory country specific intelligence for more than 5 years in some countries where Zeincro operates.

    Number of Clients - end of 2017:  85 +