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)