Global Safety Lead - Formulation Safety

CSL Ltd

Multiple Locations
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Clinical safety expertise
Safety risk management
Pharmacovigilance
** CSL Ltd is seeking a Global Safety Lead for Formulation Safety to oversee clinical safety throughout a product's lifecycle, emphasizing safety risk management and compliance with regulatory requirements. The ideal candidate will have a medical degree, pharmaceutical industry experience, and a strong background in safety evaluation. **

Job Summary

  • Provide expertise on all aspects of clinical safety throughout the entire lifecycle of a product with special emphasis on ongoing evaluation of safety information during clinical development and post approval.
  • Oversees safety management teams ensuring a thorough and consistent approach to the review of safety data emerging from clinical trials and from the post-marketing environment.
  • Ensures timely production of aggregate reports and answers to queries from Health Authorities according to consistent quality standards.

Matching Summary

Match Score: 75

** CSL Ltd is seeking a Global Safety Lead for Formulation Safety to oversee clinical safety throughout a product's lifecycle, emphasizing safety risk management and compliance with regulatory requirements. The ideal candidate will have a medical degree, pharmaceutical industry experience, and a strong background in safety evaluation. **

Skills & Requirements

Must-have

  • Clinical safety expertise
  • Safety risk management
  • Pharmacovigilance
  • Signal detection and evaluation
  • Regulatory agency requests

Nice-to-have

  • Cross-functional team representation
  • Proactive risk mitigation
  • Patient and public health protection

Key Requirements

  • MD or international equivalent plus accredited residency
  • 2+ years physician patient care experience
  • 3+ years pharmaceutical/biotechnology industry experience
  • 1+ year medical oversight/evaluation or clinical development experience
  • Designated therapeutic area experience

Work Rights

Not specified

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