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.
The challenge: In the context of a major corporate reorganisation, a large, globally operating pharmaceutical company requires re-designing of all pharmacovigilance processes to suit the future environment. The set of new written procedures is required to be agreed, written, 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.