Pharmacovigilance

Local PV Services

1.LQPPV provision
2.Local Regulatory Review & Validation
3.Medical & pharmaceutical information provision

SAE Processing

Scientific Literature Screening

Regulatory Intelligence on PV

Document Preparation & Maintenance

1.Standard Operating Procedure SOP
2.PV System Master File PSMF
3.Periodic Safety Update Report PSUR
4.Risk Management Plan RMP

Safety Reporting

1.CSRs preparation, submission & follow-up
2.Safety information reconciliation
3.Safety database for reporting & archiving