Overview
Regulators in our markets increasingly require marketing authorisation holders and their local partners to operate pharmacovigilance systems: collect adverse event reports, submit them within deadlines and maintain periodic safety documentation.
We help manufacturers and distributors establish proportionate pharmacovigilance arrangements, coordinate local contact persons and keep reporting obligations under control.
What we offer
- Pharmacovigilance system design and PV system master file support
- Adverse event intake, triage and expedited reporting coordination
- Coordination of local qualified persons for pharmacovigilance
- Periodic safety update report (PSUR) compilation support
- Literature monitoring and signal management support
- Pharmacovigilance training for distributor and sales staff
How it works
- 1
Obligation mapping
We identify PV requirements per product and market.
- 2
System setup
Procedures, templates and local contact arrangements.
- 3
Operation
Case intake, reporting and periodic documentation.
- 4
Review
Periodic audits and continuous improvement.
Benefits
Regulatory compliance
Reporting deadlines met across markets.
Proportionate cost
PV arrangements scaled to your portfolio.
Patient safety
Faster detection and communication of safety issues.
Trained partners
Distributor staff who know what to report and when.
