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

Auditing and quality assessment (QA):
- Standard operating procedure (SOP) writing
- Gap analysis
- Audit readiness support
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
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)