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.
Are we prepared for a 'hard brexit' or still hoping it will not happen?
If you are one of the Marketing Authorisation Holders (MAHs) that are still hoping for a ‘softer’ Brexit, the message from the EMA is clear: you need to prepare for the ‘hard’ Brexit scenario.
Read MoreBeyond Brexit: Diamond Secures EU Business Continuity
Diamond Pharma Services (DPS) announce the opening of EU Headquarters in The Netherlands to maintain continuity of services through the Brexit process. The opening of Diamond Pharma Services B.V. also adds to our existing EU office in Sofia, increasing our footprint in continental Europe.
Read More