- Pharmacovigilance System Master File (PSMF)
- Operating procedures and work instructions
- Maintenance of the quality management system that supports PhV activities
- Local and international literature monitoring
- ICSR (Individual Case Study Report) management
- PSUR (Periodic safety update reports) and RMP (Risk Management Plan) elaboration
- Signal Management
- PhV training
- Local QPPV
- Audit and Inspection Support