Our experience. Your safety.
With higher expectations and tougher approaches to European drug safety, PharOS employs a dedicated, well-informed Pharmacovigilance department committed to your needs by offering a range of Pharmacovigilance solutions:

• Qualified Person for Pharmacovigilance (24-hours service) – MA submission and post marketing
• Periodic Safety Update Reports (PSURs)
• Individual Case Safety Reports, AE & SAE Data Entry
• Electronic Reporting of ICSRs to the EMEA and/or Competent Authorities via the EVWEB service
• Eudravigilance Registration
• Eudravigilance Medical Product Dictionary (EVMPD) & maintenance
• Weekly Literature Searching
• SOP Development
• MedDRA Coding of adverse events
• Preparation/Review/Update of SmPCs
• Pharmacovigilance Training