Our pharmacovigilance and medical teams work closely together to provide a comprehensive suite of pre- and post-marketing pharmacovigilance services.

We utilise our fully compliant industry-standard safety database (ARGUS). The database allows secure client access to their trials or products and can be configured for worldwide case reporting requirements.

As well as an ‘EU Qualified Person for Pharmacovigilance’ (QPPV), our team also includes local pharmacovigilance representatives in all territories that require them to ensure local country compliance.

Our specialist pharmacovigilance team covers the following services:

Pre-Approval Services

  • Provision of a ‘Responsible Person’ for EudraVigilance

  • EudraVigilance and extended EudraVigilance Medicinal Product Dictionary (XEVMD) registration and maintenance

  • Medical review and assessment of serious adverse events (SAE)

  • Suspected unexpected serious adverse reaction (SUSAR), reporting to EudraVigilance and involved competent authorities

  • Ongoing medical safety surveillance and benefit-risk evaluation

  • Preparation and submission of development safety update reports (DSUR)

Peri- and Post-Approval Services

  • Preparation and maintenance of pharmacovigilance system master files (PSMF)

  • Provision of an EU Qualified Person for Pharmacovigilance (QPPV) for authorised products
  • Provision of a local ‘Qualified Person’ for pharmacovigilance (QPPV) in territories that require them

  • Planning and conduct of pharmacovigilance audits

  • EudraVigilance registration and maintenance

  • Literature surveillance

  • Individual case study report (ICSR) to EudraVigilance and competent authorities

  • Preparation and submission of periodic safety update reports (PSUR) and periodic benefit risk evaluation report (PBRER)

  • Ongoing signal management and benefit-risk evaluation

  • Support with product safety data evaluation and compilation of risk management plans (RMP)

Get In Touch

Our team is ready and willing to support your pharmacovigilance needs.

To discuss your specific project requirements, contact us today.