Pharmacovigilance Services
                                     Mark Waring

Pharmacovigilance system and process consulting

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 outsourcing: support with scoping, service model and vendor selection, and contracting.
Case study

The challenge: In the context of a major corporate reorganisation, a large, globally operating pharmaceutical company requires transferral of all pharmacovigilance practices into new processes that will suit the future environment. The new procedures are required to be approved, trained and effective within 8 months.

Our contribution: In close co-operation with client subject matter experts and PV management, Mark Waring Pharmacovigilance Services reviews and re-designs all pharmacovigilance processes, and authors more than 20 corresponding Policies and SOPs. The project is completed on schedule.

The outcome: The revised pharmacovigilance system proves fit for purpose in daily business, audits and inspections, with only minor modifications in the following years.

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