The regulatory requirements in Pharmacovigilance are remarkably complex and the monitoring of drug safety/Pharmacovigilance both in clinical trials and post approval/post marketing are essential responsibilities for pharmaceutical companies. I am providing support in the following areas:

  • Support / preparation of periodic reports (e.g., PSURs, ASRs, DSURs)
  • Analysis, preparation and medical evaluation of Individual Case Safety Reports (ICSRs) from spontaneous reporting system including literature and from clinical trials
  • Data entry, evaluation and management of ICSRs in safety databases (including MedDRA coding)
  • Preparation of workflows for compilation management and reporting of ICSRs and periodic reports (SOPs and working procedures, etc.)
  • Analysis of reporting obligations
  • Preparation, review and update of reporting obligations (adjustment with EU-regulations, directives and guidelines, local regulations)
  • Consulting on company-owned Pharmacovigilance system (Pharmacovigilance System Master File, Risk Manegement, etc.)
  • Training of staff