PrimeVigilance
Provider of end-to-end pharmacovigilance and medical information services across clinical development and post-marketing lifecycles. Capabilities include individual case processing, signal detection and management, benefit–risk assessment, regulatory representation and pharmacovigilance system master file (PSMF) management, literature surveillance, medical information operations, safety database implementation and migration, automation and workflow optimisation, regulatory intelligence and inspection readiness. Offers local regulatory support and regional operational setup across multiple territories. Part of the Ergomed Group.
Industries
N/A
Nr. of Employees
small (1-50)
Services
End-to-end processing of individual case safety reports from multiple sources.
Ongoing signal detection, evaluation and literature monitoring to identify and assess safety concerns.
Provision of qualified regulatory representation and maintenance of pharmacovigilance system master files.
Audits, remediation and inspection support spanning PV and wider GxP quality assurance to prepare for regulatory scrutiny.
Management of medical enquiries and provision of global medical communications and telephony, including local-language MI setups.
Implementation and migration services for enterprise PV/safety database platforms and associated reporting systems.
End-to-end processing of individual case safety reports from multiple sources.
Ongoing signal detection, evaluation and literature monitoring to identify and assess safety concerns.
Provision of qualified regulatory representation and maintenance of pharmacovigilance system master files.
Audits, remediation and inspection support spanning PV and wider GxP quality assurance to prepare for regulatory scrutiny.
Management of medical enquiries and provision of global medical communications and telephony, including local-language MI setups.
Implementation and migration services for enterprise PV/safety database platforms and associated reporting systems.
Expertise Areas
- End-to-end pharmacovigilance operations
- ICSR processing and case management
- Signal detection and signal management
- Benefit–risk assessment and risk management planning
Key Technologies
- Enterprise safety database platforms
- Automation and workflow orchestration for PV operations
- Telephony and global medical information systems
- Cloud-based analytics and reporting
News & Updates
Announcement regarding change of board chair for the Ergomed Group.
Webinar discussing regulatory compliance, governance and future trends for AI in life sciences and pharmacovigilance.
Case study describing the expansion of medical information services into Japan and the operational steps taken to establish local MI capability.
Achieved ISO 9001:2015 certification for the global quality management system.
Achieved Leader status in Everest Group PEAK Matrix assessment for pharmacovigilance operations.
Press release announcing rebranding from previous corporate identity to PrimeVigilance.
Announcement regarding change of board chair for the Ergomed Group.
Webinar discussing regulatory compliance, governance and future trends for AI in life sciences and pharmacovigilance.
Case study describing the expansion of medical information services into Japan and the operational steps taken to establish local MI capability.
Achieved ISO 9001:2015 certification for the global quality management system.
Achieved Leader status in Everest Group PEAK Matrix assessment for pharmacovigilance operations.
Press release announcing rebranding from previous corporate identity to PrimeVigilance.