Exploitant - Pharmaceutical Establishment

Pharmacovigilance

  • For the head pharmacist (PR) for managing the local pharmacovigilance system and liaising with the parent company
  • For the pharmacovigilance reference person (RPV) for performing his/her duties
  • Drafting or reviewing your PSMF (global, local)
  • Pharmacovigilance quality management system: drafting and reviewing procedures tailored to your organization and product portfolio
  • Assistance with monitoring vigilance service providers, service provider qualification audits, etc.
  • Preparing PV experts and non-experts by theme
  • Assistance with implementing and monitoring CAPAs
  • Supporting improvement of the PV system
  • Clinical trial vigilance
  • Post-marketing pharmacovigilance
  • Sales force training

Conducting audits and assessments

Consultancy on the regulation of post-marketing pharmacovigilance and clinical trials

Further information

Download the document "Les activités d'Exploitant pharmaceutique"

Atessia will support you in your pharmacovigilance activities thanks to its extensive experience in both corporate and subsidiary organizations and through exclusive support for Head Pharmacists in both training and preparing inspections.