Medical Affairs
Pharmacovigilance
Pharmacovigilance services include
- Pharmacovigilance strategies, premarketing risk analysis, risk evaluation and mitigation
- Support client needs relevant to pharmacovigilance guidelines and regulations
- Prepare/review safety sections for regulatory filings including integrated safety summaries
- Provide medical review of trial data for the detection and evaluation of safety signals in clinical/safety databases
- Reconciliation of clinical AEs and SAEs
- Safety system and standard operating procedures gap analysis
- Research drug safety topics
- Provide medical/safety support for abstracts and publications
