Our pharmacovigilance

We have a team of safety scientists and physicians supporting a wide range of pharmacovigilance (PV) services. Our activities range from auditing/quality assessment, to post-marketing and clinical safety.

Services included : 

  1. Auditing and quality assessment (QA):
    • Standard operating procedure (SOP) writing
    • Gap analysis
    • Audit readiness support
  2. Post-marketing:
    • Local Qualified Person for Pharmacovigilance (QPPV) services
    • Aggregate reports (preparation and updates):
      • Periodic Benefit Risk Evaluation Report (PBRER)/ Periodic Safety Update Report (PSUR)
      • Periodic Adverse Drug Experience report (PADER)
      • Addendum to Clinical Overview (ACO)
      • Risk Management Plan (such as EU RMP, core RMP, local RMP and region-specific annexes), including development of strategies for PV activities and risk minimization measures
    • Signal detection and management
    • Drug Safety Physician service
  3. Clinical Safety:
    • Set-up of clinical safety activities for sponsors
    • Preparation of Development Risk Management Plans (dRMPs), Development Safety Update Report (DSUR)
    • Drug safety physician service (including DSMB)
    • Signal detection and management
    • Safety Management Plan drafting
    • EudraVigilance activities, Responsible Person of EV, product registration in the extended EudraVigilance medicinal product dictionary (XEVMPD)

Other services

We offer a wide range of projects. Click on the icons below for more info.