CSO Pharma Consulting GmbH
CSO Pharma is an independent German consulting and service company dedicated to compliance, safety, and development in the pharmaceutical sector. They support pharmaceutical companies and healthcare providers with services in pharmacovigilance, medical affairs, quality management, regulatory compliance, and organization development. Their mission is to provide reliable, compliant, and strategic support to help clients meet regulatory requirements and improve their processes. They value integrity, reliability, and trustworthiness, and focus on individual and future-oriented solutions to ensure customer satisfaction and regulatory compliance.
Industries
Nr. of Employees
small (1-50)
CSO Pharma Consulting GmbH
Services
End-to-end implementation and updating of PV systems, documentation (PSMF), SOPs and integration with QMS.
Receipt, assessment, database entry and electronic reporting of ICSRs, plus follow-up case management.
Signal detection and validation services, medical literature monitoring and preparation of PSUR/PBRER and DSUR documents.
Medical/scientific enquiry handling via hotline, dedicated email/fax and online portal with client-specific access and statistics.
Review, update and prepare product information, PILs/SPCs, labeling QM and assessments for advertising law compliance.
Checklist-driven data entry, acknowledgement evaluation, update/version control and documentation for EU product dictionary submissions.
End-to-end implementation and updating of PV systems, documentation (PSMF), SOPs and integration with QMS.
Receipt, assessment, database entry and electronic reporting of ICSRs, plus follow-up case management.
Signal detection and validation services, medical literature monitoring and preparation of PSUR/PBRER and DSUR documents.
Medical/scientific enquiry handling via hotline, dedicated email/fax and online portal with client-specific access and statistics.
Review, update and prepare product information, PILs/SPCs, labeling QM and assessments for advertising law compliance.
Checklist-driven data entry, acknowledgement evaluation, update/version control and documentation for EU product dictionary submissions.
Expertise Areas
- Pharmacovigilance and drug safety
- Medical Affairs and medical information
- Quality Management Systems and GxP compliance
- Regulatory affairs and lifecycle management
Key Technologies
- Pharmacovigilance databases and ICSR processing
- Regulatory adverse-event reporting systems and electronic monitoring
- xEVMPD / EVMPD and ISO IDMP data standards and submissions
- Online service portals with audit trail and secure access
News & Updates
CSO Pharma is looking for motivated candidates for pharmacovigilance and medical affairs roles. Send applications to jobs@cso-pharma.eu.
Opportunity to join as a Pharmacovigilance Advisor in Munich, with tasks including safety report processing, literature screening, and risk management.
CSO Pharma is looking for motivated candidates for pharmacovigilance and medical affairs roles. Send applications to jobs@cso-pharma.eu.
Opportunity to join as a Pharmacovigilance Advisor in Munich, with tasks including safety report processing, literature screening, and risk management.