Safety Database Management
Pharmacovigilance
An efficient and compliant PV system relies heavily on a well-maintained safety database that meets global regulatory requirements. According to EU GVPs, MAHs must ensure that adverse event data are accurately collected, stored, and reported in a timely manner.
PVpharm offers flexible Safety Database Management services tailored to your needs — from setup and configuration of validated safety databases to ongoing maintenance and regulatory submissions.
Our services include:
- Database management: database setup and configuration aligned with your safety data workflows.
- Safety data management: Data entry and validation of ICSRs and other pharmacovigilance data.
- ADR codification: Coding support using MedDRA and WHO Drug Dictionaries.
- QC and AE reconciliation: Quality control and reconciliation to maintain accuracy and completeness.
- ICSR/SUSAR submission: Electronic regulatory submissions through EudraVigilance, FDA FAERS, and other portals.
- Database maintenance: Maintenance and upgrades to ensure database performance and compliance with evolving regulatory requirements.
