Safety Assistant Manager

CSL Behring

Gcp and gvp compliance knowledge
Ae and infection case evaluation
Pmda reporting procedures
The role involves managing safety-related information for investigational and marketed products in strict accordance with GCP and GVP standards

Job Summary

  • The role involves managing safety-related information for investigational and marketed products in strict accordance with GCP and GVP standards.
  • Responsibilities include evaluating adverse events, preparing periodic reports for authorities like the PMDA, and maintaining the Organized Data Collection System.
  • CSL Behring is a global biotherapeutics leader committed to saving lives through innovative therapies and fostering a diverse, inclusive workforce.

Matching Summary

The role involves managing safety-related information for investigational and marketed products in strict accordance with GCP and GVP standards.

Skills & Requirements

Must-have

  • GCP and GVP compliance knowledge
  • AE and infection case evaluation
  • PMDA reporting procedures
  • CTD1.11 J-RMP preparation
  • ODCS system management

Nice-to-have

  • Global organization coordination
  • Vendor management experience
  • SOP and document control skills
  • Training and outsourcing support
  • Inclusion and belonging culture

Key Requirements

  • Experience with Japanese regulatory requirements
  • Knowledge of GVP/GPSP standards
  • Ability to manage vendor agreements

Work Rights

Not specified

Tailored Resume

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