Pharmacovigilance

We offer a broad range of Pharmacovigilance services which include:

• Preparation for Pharmacovigilance audits
• Safety database set-up and support
• Annual Safety Reports
• Post-Approval safety reporting
• Periodic Safety Update Reports (PSURs)
• Processing of AE reports from Clinical Trials/Post-Approval use
• Monthly line listings
• Risk Management Plans
• Literature searching
• Qualified Person for Pharmacovigilance (QPPV)
• Standard Operating Procedures (SOPs) Preparation

Pharmacovigilance (PV or PhV) spans the life cycle of a product and is the science of monitoring, researching and evaluating information from healthcare providers and patients on the adverse effects of medicines. This information is then used to identify potential new hazards, prevent harm to patients and improve safety reporting.

All MA holders in Europe are required to submit adverse drug reaction reports. The European Medicines Agency (EMA) is then responsible for coordinating and maintaining a pharmacovigilance database that contains all suspected serious adverse reactions to medicines observed throughout Europe to improve drug safety.

TRAC's experts can support you through all areas of the Pharmacovigilance system and safety reporting. From one off projects, such as preparation of Standard Operating Procedures to the provision of regular off-site resource to complete tasks such as literature searching or case assessments, we can help you achieve good Pharmacovigilance practice and provide peace of mind that all requirements are being met.

We work with clients to develop, implement and run all areas of a compliant PV system.

For more information please download our brief guide to Pharmacovigilance. If you have any further questions regarding Pharmacovigilance please Contact Us.