Our pharmacovigilance department manage the outsourced post market support for a diverse range of clients of all sizes from small generics companies through to large multinational organisations. We hold a niche position in the PV services market by being flexible enough to offer bespoke services, but with the internal capabilities to handle large case volumes.

Our services include:

• Full range of products including generics, innovator products, advanced therapies
• QPPV services
• 24-hour Pharmacovigilance cover
• Support for EU companies with no presence in UK & Ireland
• Medical Information service
• Electronic management of Adverse Event reports on the ARISg™ database
• Electronic expedited reporting (EudraVigilance)
• Literature Search and Reviews
• Signal detection
• Periodic Safety Reports (PSURs)
• EudraVigilance set up and oversight
• Auditing of PV systems
• Risk Management Plan (RMP) writing
• PV training.

We provide 24-hour cover for enquiries, handling receipt, logging and follow-up of medical information via the Diamond PV Medical Information Hotline.

The regulatory landscape for medical devices has undergone significant change, but our team can provide a robust solution for your medical device vigilance programmes by providing the following services:

• Device Vigilance Project Management
• Collection and follow-up of Medical Device Incidents
• Weekly literature searches of Medline
• Electronic management of Incidents on the ARISg™ database
• Expedited reporting of Medical Device Incidents to Competent Authorities
• Distribution of Field Safety Corrective Actions and Field Safety Notices.