Safety Assistant Manager

CSL Ltd

Tokyo, Japan
On-site
Gcp and gvp compliance
Safety information management
Regulatory reporting to authorities
CSL Ltd is seeking a Safety Assistant Manager in Tokyo, Japan, who will be responsible for managing safety-related information for investigational and marketed products, ensuring compliance with GCP and GVP standards. The ideal candidate will have experience in safety management and regulatory reporting within the biotherapeutics or pharmaceutical industry

Job Summary

  • Handle and assist management of safety related information of investigational products in accordance with GCP and support development tasks.
  • Plan and implement measures for securing safety such as information providing/disseminating, and assist management of those tasks.
  • Implement and assist management of other GVP/GCP activities including archiving, SOP management, training, and outsourcing.

Matching Summary

Match Score: 85

CSL Ltd is seeking a Safety Assistant Manager in Tokyo, Japan, who will be responsible for managing safety-related information for investigational and marketed products, ensuring compliance with GCP and GVP standards. The ideal candidate will have experience in safety management and regulatory reporting within the biotherapeutics or pharmaceutical industry.

Skills & Requirements

Must-have

  • GCP and GVP compliance
  • Safety information management
  • Regulatory reporting to authorities
  • SOP and document management
  • Vendor management
  • Organized Data Collection System (ODCS)

Nice-to-have

  • Support development tasks
  • Global organization collaboration
  • PMDA inquiry response
  • CSL Behring values

Key Requirements

  • GCP compliance
  • GVP compliance
  • GPSP compliance

Work Rights

Not specified

Tailored Resume

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