The role involves handling and assisting management of safety related information for investigational and marketed products in accordance with GCP and GVP standards
Job Summary
The role involves handling and assisting management of safety related information for investigational and marketed products in accordance with GCP and GVP standards.
CSL Behring is a global biotherapeutics leader focused on innovative therapies and operates one of the world’s largest plasma collection networks.
CSL fosters a culture of inclusion and belonging that fuels innovation and supports a diverse workforce.
Matching Summary
The role involves handling and assisting management of safety related information for investigational and marketed products in accordance with GCP and GVP standards.
Skills & Requirements
Must-have
GVP and GCP compliance
Safety information management
SOP and document management
Vendor management and agreements
Organized Data Collection System (ODCS)
Safety reporting to authorities
Global safety information exchange
Nice-to-have
Training and outsourcing management
Cross-functional team collaboration
Inclusion and belonging culture
Support development tasks
Coordination with global organizations
Key Requirements
Experience with GVP/GCP activities
Knowledge of safety management information evaluation
Ability to prepare and submit regulatory reports
Experience managing SOPs and training
Vendor and PVA agreement management
Familiarity with CTD1.11 (J-RMP) and PMDA inquiries