Global Safety Lead - Formulation Safety

CSL Behring

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Clinical safety data analysis
Signal detection and risk management
Regulatory compliance with pv tasks
** CSL Behring is seeking a Global Safety Lead for Formulation Safety, responsible for overseeing clinical safety throughout the product lifecycle, emphasizing safety evaluation during clinical development and post-approval. The role requires expertise in safety risk management, regulatory compliance, and cross-functional collaboration. **

Job Summary

  • The role provides expertise on all aspects of clinical safety throughout the entire lifecycle of a product with special emphasis on ongoing evaluation during clinical development and post approval.
  • The position is responsible for setting safety strategy for global projects and ensuring alignment with legal requirements and company standards of Pharmacovigilance tasks.
  • CSL Behring is a global biotherapeutics leader driven by a promise to save lives, offering a culture where inclusion and belonging fuel innovation day in and day out.

Matching Summary

Match Score: 75

** CSL Behring is seeking a Global Safety Lead for Formulation Safety, responsible for overseeing clinical safety throughout the product lifecycle, emphasizing safety evaluation during clinical development and post-approval. The role requires expertise in safety risk management, regulatory compliance, and cross-functional collaboration. **

Skills & Requirements

Must-have

  • Clinical safety data analysis
  • Signal detection and risk management
  • Regulatory compliance with PV tasks
  • DSUR PSUR and RMP production
  • Cross-functional team leadership

Nice-to-have

  • Strong product knowledge in therapeutic areas
  • Experience in pre-approval and post-approval environments
  • Proactive approach to safety issue mitigation
  • Medical judgment for complex data interpretation

Key Requirements

  • MD or international equivalent plus accredited residency
  • Minimum 2 years physician patient care experience
  • 3+ years pharmaceutical industry experience with medical oversight
  • Experience addressing complex medical issues in pre/post approval

Work Rights

Not specified

Tailored Resume

Cover Letter