Our Global Pharmacovigilance System has been developed over a number of years and improved and refined with every audit and review that has been performed.
We have a number of suitably qualified personnel in-house (Pharmacists and Medical Doctors) with substantial experience both from industry and also from the Competent Authority side. The system is maintained by an experienced European Union Qualified Person (EUQPPV) and Deputy Qualified Person.
Behind this, we have a 21CFR validated Pharmacovigilance database.
Some of the key elements of our offering are:
- Provision of a fully outsourced Pharmacovigilance system utilising:
- Our in-house European Union Qualified Person (EUQPPV) and Deputy QPPV with experienced support of Medical Doctors & Pharmacists with Regulatory Agency Experience
- PV Database
- Embase Global Literature Screening – Global / Local & Individual Case Safety Reports (ICSR’s)
- Management of all local QPPVs/Contact Persons (globally)
- Management of all local Pharmacovigilance Literature Screening (globally)
- Development of Standard Operating Procedures (SOPs) / Quality Management System (QMS) Preparation and Implementation
- Extended Medicinal Product Dictionary (xEVMPD) / ISO Investigational Medicinal Product Dossier (IMPD) Support
- Pharmacovigilance System Master Files (PSMFs) - Periodic Safety Update Reports (PSURs) - Development Safety Update Reports (DSURs) preparation
- Risk Management Plans (RMPs)
- Pharmacovigilance Regulatory Intelligence
- Data & Signal Management
- Audit and Inspection Readiness - AIR™