Working towards "State-of-the-Art" within Pharmacovigilance


Let Audit PV be your preferred partner

Audit PV has gained expertise through working with various organisations and is happy to offer the following services:


Good Vigilance Practice Audits

The objective of a pharmacovigilance audit is to "verify, by examination and evaluation of objective evidence, the appropriateness and effectiveness of the implementation and operation of a pharmacovigilance system, including its quality system for pharmacovigilance activities.

Audit PV is able to audit the pharmacovigilance system for companies globally against European, US-FDA and Asia-Pacific authority standards.


Mock Inspections & Inspection Readiness

As part of the audit offering Audit PV is also able to conduct Mock interview sessions and assisting in preparing companies for forthcoming inspection.


Full & Partial Pharmacovigilance System services


  • QPPV services
  • Pharmacovigilance System Master File (PSMF) Generation and maintenance
  • Case reports management through to adverse event submissions
  • Continual safety surveillance and signal detection
  • Risk Management Plans (RMP) creation and maintenance
  • Risk-benefit management and analysis
  • Preparation of periodic Benefit-Risk Evaluation Reports (PBRERs)
  • Crisis management including interfaces with quality for recalls
  • Creation and maintenance of Safety Data Exchange Agreements with Third parties
  • Database implementations including validation
  • Change management
  • Provision of medical information services


Pharmacovigilance Training

Audit PV has trained company employees and service providers globally through in-house training and conferences. The training provided can be tailored by the client from basic training on an annual basis of all company employees through to advanced training of pharmacovigilance departments in specific disciplines.


Quality Management System Consultation

Audit PV can work towards implementing or improving your pharmacovigilance quality management system to mirror the definitions accepted by the competent authority (defined as as a management system to direct and control an organisation with regard to quality).