Post-marketing Pharmacovigilance:

• Drug Safety Project Management
• Collection and follow-up of Adverse Drug Reactions (ADRs) originating from all post-market sources
• Weekly literature searches of Medline
• Electronic management of ADRs on the ARISg database
• Electronic expedited reporting to Competent Authorities
• Eudravigilance set up and management
• EU Qualified Person for Pharmacovigilance (QPPV) and deputy QPPV oversight
• Reconciliation with Medical Information
• Compliance oversight
• Signal Detection
• 24 hour cover
• Filing and archiving