Pharmacovigilance &
Drug Safety
The Public Website Does Not Currently Present A Dedicated Pharmacovigilance Service Page. The
Following Is Recommended Expansion Content And Should Be Published Only After Confirming
Operational Capability And Applicable Regional Requirements.
Our clinical services
Pharmacovigilance & Drug Safety
Our pharmacovigilance model is designed to support the identification, assessment, documentation and communication of emerging safety information throughout clinical development and post-marketing use.
Pharmacovigilance & Drug Safety Scope
Individual Case Safety Report (ICSR) Intake, Triage And Processing- Case Validation And Duplicate Assessment
- Medical Review And Clinical Assessment
- Seriousness, Expectedness And Causality Assessment Support
- MedDRA / Controlled Terminology Coding
- Safety Narrative Preparation
- Regulatory Safety Reporting Support
- Follow-Up Case Management
- Signal Detection And Signal Evaluation Support
- Aggregate Safety Reporting
- Pharmacovigilance System Documentation
- Safety Database Support
- Medical Information / Product-Information Support
Pharmacovigilance Workflow
Case
Intake
Validation
& Triage
Medical
Review
Coding
Narratives
Submission /
Follow-Up
Signal &
Aggregate Review
Potential Deliverables
ICSR Packages
Safety Narratives
Literature Screening Records
Signal Evaluation Reports
PSUR/PBRER Support
DSUR Support
RMP Support
PSMF Support
Safety Database Reconciliation
Stay connected with science
Stay connected with scienceStay Informed. Stay Ahead in Research.
Subscribe to receive the latest updates on pharmaceutical research, clinical and pre-clinical testing, medical device safety, regulatory developments, scientific insights and industry events from Ribosome Research Centre.