Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medicinal products, biological products, herbals and traditional medicines with a view to:

• identifying new information about hazards associated with medicines
• preventing harm to patients

The continuous development of pharmacovigilance began in the sixties ("Contergan-Tragedy) till the contemporary European functional databank EudraVigilance for notification of serious adverse events of medicinal products. The EudraVigilance User certificate guarantees the assumption of all tasks of an EU-QPPV. As a matter of course pharmacovigilance of veterinary products can also be handled. Medical Device Vigilance takes attention in an early stage of development and is a part of qualification of a medical device.

Overview about Pharmacovigilance and Medical Device-Vigilance activities: 

• Pharmacovigilance System - consultation, buildup, implementation
• Pharmacovigilance SOPs - writing, review and revision
• Pharmacovigilance Plan (product authorisation)
• Qualified Person Pharmacovigilance services – including certified use of EudraVigilance (EudraVigilance User certificate)
• Notification of Pharmacovigilance events, quality deficiencies and quality related issues
• Notification of incidents or near incidents in medical devices
• EudraVigilance - EV-registration, database use, medical evaluation, etc.
• Preparation of Pharmacovigilance documents – case files, evaluation report, etc.
• PSURs – creation, review, etc.
• Literature research and reports
• Pharmacovigilance database - consultancy and support
• Pharmacovigilance Trainings