Pharmacovigilance & Device Vigilance
Safety monitoring, reporting, and risk management across global markets.
Pharmacovigilance for drugs and biologics
- AE/SAE processing:
Case intake, medical review, and ICSR generation - Signal detection:
Statistical monitoring and safety signal evaluation - Periodic reporting:
PSUR, DSUR, and annual safety reports
- AE/SAE processing:
Medical device vigilance and safety monitoring
- Incident reporting:
Device malfunction and serious incident processing - Post-market surveillance:
PMCF studies and safety data collection - MDR compliance:
Vigilance reporting and regulatory notifications
- Incident reporting:
Safety database management and reporting
- Database setup:
Safety system implementation and validation - Case management:
Intake processing, coding, and quality control - Automated reporting:
Regulatory submission generation and distribution
- Database setup:
Risk management and mitigation strategies
- Risk assessment:
Benefit-risk evaluation and safety profiling - RMP/REMS development:
Risk management plans for EU and US markets - Mitigation programs:
Safety communications and educational materials
- Risk assessment:
Regulatory safety compliance and submissions
- Global reporting:
Multi-regional submission timelines and requirements - Compliance monitoring:
Documentation, training, and quality assurance - Inspection readiness:
Audit preparation and regulatory correspondence
- Global reporting:
