Clinical Trial Pharmacovigilance:

• Drug Safety Project Management
• Collection and follow-up of Serious Adverse Events (SAEs) from clinical trials
• Electronic management of SAEs on the ARISg database
• Expedited reporting to Competent Authorities
• Expedited reporting to Ethics Committees and investigator sites
• Six monthly and quarterly reporting to Competent Authorities and Ethics Committees
• Responsible Person for Eudravigilance oversight
• Reconciliation with clinical database
• Compliance review and oversight
• Eudravigilance set up and management
• Signal Detection
• 24 hour cover
• Filing and Archiving