PV Safety System Support & Maintenance

We bring in a rare but solid combination of seasoned professionals with techno-functional expertise in end-to-end safety system support & maintenance which includes all the systems and processes aligned with the safety databases.

• End-to-end Safety system support & maintenance for Argus Safety, ArisG, Veeva and other safety databases 
• Integration of safety database with Signal management systems like Empirica, CVW, and other signalling solutions 
• Qualitative & Quantitative analysis using data mining and statistical method in signals solutions 

• Consultation on Medical Devices safety reporting in MIR (Manufacturer Incident Report) format as well as in signal detection solutions for Medical Devices 
• Multiple E2B Agency setup with Axway interchange, and other gateways 
• All sorts of ad-hoc & periodic report generations including CIOMS-II, DSUR, PSUR, SUSAR, PBRER, NDA, etc  
• Ensuring 24X7 sincere and value-added global support excelling the company’s SLA and KPIs 
• Helping our clients in Audits & Inspections, ensuring compliance is met from the PV Safety side.