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