The International Regulatory Affairs Network
Pharmacovigilance
- Services of an EEA-Qualified Person for Pharmacovigilance
- Pharmacovigilance Quality System preparation and management
- Good Pharmacovigilance Practice auditing
- Post marketing case processing management including EudraVigilance reporting
- Signal detection
- Global and local literature reviews
- Safety database management
- Periodic Safety Update Report preparation
- Risk Management Plan preparation
- Clinical trial pharmacovigilance services including preparation of Development Safety Update Reports and case processing
- Pharmacovigilance pre and post-marketing project management services
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