Pharmacovigilance & Materiovigilance

 

ICSR-Individual case safety reports

Intake, triage, processing and reporting of adverse event reports in safety database from clinical, post-marketing, literature and partners

Aggregate Reports

Prepare and submit PSUR, PBRER, PADER, DSUR, Annual Report and device post marketing safety reports

Signal Detection & Risk Management

Prepare periodic signal reports, RMPs, REMS documentation, medication guides

Safety Strategy

 

Cost efficient

PVRM Plus provides cost efficent solutions for managing end-to-end safety solutions

Secure database

We can liaise to establish secure database for processing safety reports 

Uncompromised quality

Maintain quality standards at both an individual and holistic level of operations to produce outstanding results

Compliance standards

Strict adherence and attention to the diverse regulation requirements to maintain high compliance standards