Post market pharmacovigilance support
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.
Post Market Medical Information
We provide 24-hour cover for enquiries, handling receipt, logging and follow-up of medical information via the Diamond PV Medical Information Hotline.
Medical Device Vigilance
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.