PSR Group
PrimeVigilance is a global provider of pharmacovigilance, medical information, and regulatory services, dedicated to supporting pharmaceutical companies worldwide with high-quality safety, pharmacovigilance, and medical information operations. The company emphasizes quality, operational excellence, and innovative technology-driven solutions to ensure patient safety and regulatory compliance. Recognized for substantial growth and excellence, PrimeVigilance offers comprehensive services across the entire lifecycle of pharmacovigilance, including benefit-risk management, case processing, safety reporting, signal management, and more. The company also provides specialized product expertise, insights, webinars, and participates in industry events, maintaining a strong leadership position in the pharmacovigilance industry.
Industries
Nr. of Employees
small (1-50)
PSR Group
Hoofddorp, Noord-Holland, The Netherlands, Europe
Products
Validated safety database implementation (cloud and on‑premise integrations)
Implementation and validation of safety case management databases and web‑based medical information systems, including automated workflows, prioritisation logic, BI integration and full validation documentation.
Case Processing
Comprehensive drug safety case processing services ensuring high-quality safety and pharmacovigilance operations.
GVP Audits/Inspection Preparedness
Pharmacovigilance audit services and GVP inspection readiness support.
QPPV and PSMF
QPPV services and PSMF management for global pharmacovigilance compliance.
PVBridge™
Technology-driven solution helping clients develop internal pharmacovigilance capacity.
Safety Systems and Reporting
End-to-end safety reporting services and safety systems integration for pharmacovigilance.
Validated safety database implementation (cloud and on‑premise integrations)
Implementation and validation of safety case management databases and web‑based medical information systems, including automated workflows, prioritisation logic, BI integration and full validation documentation.
Case Processing
Comprehensive drug safety case processing services ensuring high-quality safety and pharmacovigilance operations.
GVP Audits/Inspection Preparedness
Pharmacovigilance audit services and GVP inspection readiness support.
QPPV and PSMF
QPPV services and PSMF management for global pharmacovigilance compliance.
PVBridge™
Technology-driven solution helping clients develop internal pharmacovigilance capacity.
Safety Systems and Reporting
End-to-end safety reporting services and safety systems integration for pharmacovigilance.
Services
Comprehensive PV services covering clinical safety, regulatory reporting and post‑marketing surveillance.
Operational processing of individual case safety reports with coding, quality review and timely regulatory submissions.
Multilingual medical information services with validated response workflows, integration with safety systems and options for extended hours or 24/7 coverage.
Services to manage provider or technology changes, rescue failing implementations, execute data migrations and maintain reporting compliance during transitions.
Advisory and optimisation services combining safety subject‑matter experts and technology assessment to improve PV performance and governance.
Implementation and regulatory validation of safety case management and medical information systems, including validation documentation, test plans and audit‑trail configuration.
Comprehensive PV services covering clinical safety, regulatory reporting and post‑marketing surveillance.
Operational processing of individual case safety reports with coding, quality review and timely regulatory submissions.
Multilingual medical information services with validated response workflows, integration with safety systems and options for extended hours or 24/7 coverage.
Services to manage provider or technology changes, rescue failing implementations, execute data migrations and maintain reporting compliance during transitions.
Advisory and optimisation services combining safety subject‑matter experts and technology assessment to improve PV performance and governance.
Implementation and regulatory validation of safety case management and medical information systems, including validation documentation, test plans and audit‑trail configuration.
Expertise Areas
- Pharmacovigilance and safety lifecycle management
- ICSR processing and regulatory safety reporting
- Signal detection, evaluation and management
- Benefit–risk assessment and risk management planning
Key Technologies
- Validated safety case management databases
- Cloud‑based medical information management systems
- Automated workflow and case prioritisation engines
- Business intelligence and custom reporting integration
News & Updates
PrimeVigilance was nominated for the IAE Awards 2025, recognizing excellence in pharmacovigilance.
Participation in the 2025 World Drug Safety Congress Europe.
PrimeVigilance has been nominated for the IAE Awards 2025, a recognition of its excellence in pharmacovigilance services.
PrimeVigilance received the Queen’s Award for Enterprise in the International Trade Category for substantial overseas earnings and growth over six years.
PrimeVigilance was nominated for the IAE Awards 2025, recognizing excellence in pharmacovigilance.
Participation in the 2025 World Drug Safety Congress Europe.
PrimeVigilance has been nominated for the IAE Awards 2025, a recognition of its excellence in pharmacovigilance services.
PrimeVigilance received the Queen’s Award for Enterprise in the International Trade Category for substantial overseas earnings and growth over six years.