Named-patient and Compassionate
use Programmes Pharmacovigilance:

• Drug Safety Project Management
• Collection and follow-up of Adverse Events (AEs) from named patient and compassionate use programs
• Weekly literature searches of Medline
• Electronic management of AEs on the ARISg database
• Electronic expedited reporting to Health Authorities
• Eudravigilance set up and management
• EU Qualified Person for Pharmacovigilance (QPPV) and deputy QPPV oversight
• Compliance oversight
• 24 hour cover
• Filing and archiving