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.