Pharmacovigilance System and Process Maintenance

Legislation requires that marketing authorisation holders shall establish and maintain an adequate and effective pharmacovigilance system. In an ever-changing regulatory and business environment, maintenance of a system that is both regulatory compliant and proportionate to your organisation is a challenging task. Building on years of hands-on experience, we offer:

  • Review and gap analysis of your pharmacovigilance system and processes
  • Conceptualisation and mapping of optimised processes and other system components that meet both, your organisation's needs as well as regulatory expectations
  • Preparation of corresponding system documentation, such as standard operating procedures, working instructions and templates, job descriptions, and training plans
  • Maintenance of your Pharmacovigilance System Master File.
Pharmacovigilance System Mapping