The Expertise You Need for Postmarketing Pharmacovigilance
The aim of a pharmacovigilance (PV) audit is to use objective evidence to evaluate the appropriateness and effectiveness of the implementation and operations of a PV system.
At ProPharma Group, we offer credentialed PV auditors who are objective and independent when reviewing your PV system. Many of our PV auditors are EU Qualified Persons for Pharmacovigilance (QPPVs) or have very strong backgrounds in PV in global markets, so they are fully versed in all PV legislation and understand the practical aspects of its implementation.
Wide-Ranging Knowledge for Postmarketing Auditing
Our pharmacovigilance audit capabilities are all-encompassing, covering the PV department as well as its key interfaces with regulatory affairs, medical information, clinical, quality, and commercial departments.
ProPharma Group PV auditors are an essential addition to your quality management system and help fulfill the requirements of applicable regulations, guidelines, and standards, and ensure you are always ready for an inspection. Our team has substantial experience in conducting remote or on-site audits across all aspects of your PV system. This can include audits of your company headquarters, affiliates, license partners, service providers, and distributors, as well as a range of specialized topic-specific audits to meet your business needs (e.g., case processing, aggregate reports, RMP and risk minimization, contractual partners, QMS, and PSMF).
In line with GVP Module IV, ProPharma Group can help implement a risk-based approach to PV audits and create an appropriate audit strategy, effective audit program, and robust CAPA management system.
To help companies become inspection ready, our PV consultants provide targeted inspection readiness training, facilitate interactive interview practice, and advise on technical legislative requirements.