Pharmacovigilance

  • Our Services
  • Pharmacovigilance

    Latest News


    Diamond Pharma Services will be exhibiting at the TOPRA symposium 2nd-4th October&...

    Read more


    Diamond Pharma Services has extensive experience in assisting companies to navigate thr...

    Read more


    Post Marketing Pharmacovigilance

    • Drug Safety Project Management
    • Collection and follow-up of Adverse Drug Reactions (ADRs) originating from all post-market sources
    • Weekly literature searches of Medline
    • Electronic management of ADRs on the ARISg database
    • Electronic expedited reporting to Competent Authorities
    • Eudravigilance set up and management
    • EU Qualified Person for Pharmacovigilance (QPPV) and deputy QPPV oversight
    • Reconciliation with Medical Information
    • Compliance oversight
    • Signal Detection
    • 24 hour cover
    • Filing and archiving

    Post Marketing Medical Information

    • 24 hour cover
    • Receipt, logging and follow-up of medical information enquires via Diamond PV medical information hotline

    Clinical Trial Pharmacovigilance

    • Drug Safety Project Management
    • Collection and follow-up of Serious Adverse Events (SAEs) from clinical trials
    • Electronic management of SAEs on the ARISg database
    • Expedited reporting to Competent Authorities
    • Expedited reporting to Ethics Committees and investigator sites
    • Six monthly and quarterly reporting to Competent Authorities and Ethics Committees
    • Responsible Person for Eudravigilance oversight
    • Reconciliation with clinical database
    • Compliance review and oversight
    • Eudravigilance set up and management
    • Signal Detection
    • 24 hour cover
    • Filing and Archiving
    • Named-patient and Compassionate use Programmes Pharmacovigilance:

    • Drug Safety Project Management
    • Collection and follow-up of Adverse Events (AEs) from named patient and compassionate use programs
    • Weekly literature searches of Medline
    • Electronic management of AEs on the ARISg database
    • Electronic expedited reporting to Health Authorities
    • Eudravigilance set up and management
    • EU Qualified Person for Pharmacovigilance (QPPV) and deputy QPPV oversight
    • Compliance oversight
    • 24 hour cover
    • Filing and archiving

    Medical Device Vigilance:

    • 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

    Pharmacovigilance Documentation

    PV Services can prepare the pharmacovigilance documents required by the Regulatory Authorities which include:

    • Standard Operating Procedures (SOPs)
    • Summary of Pharmacovigilance Systems (SPSs)
    • Risk Management Plans (RMPs)
    • Clinical Trial Annual Safety Reports (ASRs)
    • Named patient / compassionate use program Annual Safety Reports
    • Periodic Safety Update Reports (PSURs)

    Pharmacovigilance Audits

    Diamond PV has conducted successful audits of UK and European pharmaceutical companies leading to favorable regulatory pharmacovigilance inspection outcomes.

    In order to ensure we are providing the best PV system in conjunction with our client we undertake both self-audit by external auditors. We have also been successfully inspected by the MHRA.

    Our service provides a comprehensive assessment of the current systems in place and advice on areas that require improvement.

    Pharmacovigilance Training

    All staff who may potentially be contacted regarding an ADR must be trained on how to recognise it, how to handle it, and what to do next.

    We can provide drug safety training to staff to ensure they meet these requirements.

    We can offer more extensive training to suit individual needs, such as:

    • Pharmacovigilance Auditing
    • Volume 10 and Clinical Trials Directive Training
    • Basic Pharmacovigilance Training for non PV staff
    • Basic Pharmacovigilance Training for PV professionals
    • Intermediate Pharmacovigilance Training for PV professionals
    Responsive image