Product Vigilance
Local Scientific & Vigilance contact
Assignment of Local PV responsible and deputy, when applicable:
- Availability 24/7 to local Competent Authorities
- Participation in audits and inspections, when applicable
- Handling of local Competent Authorities requests, according to specific Work Orders
- Monitoring changes in the local legislation related to PV activities
Local Literature Search
- Definition of sources and literature searches strategies
- Literature searches performed in relevant local source in accordance to publication frequency
Management & Reconciliation
- Local processing and submission of cases if applicable
- Exchange of monthly reconciliation reports for all safety information on a monthly basis
- Local submissions for approval of Risk Management Plans, Education Materials and others.
- Continuous trainings - SOPs, WOs etc.