The role provides 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
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 of safety information 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 operates one of the world's largest plasma collection networks and delivers lifesaving therapies to people in more than 100 countries.
Matching Summary
The role provides 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.
Skills & Requirements
Must-have
Clinical safety data analysis
Signal detection and evaluation
Risk management plan development
Regulatory agency response management
Medical oversight of clinical trials
Nice-to-have
Cross-functional team leadership
Complex medical issue resolution
Patient safety advocacy
Strategic safety planning
Key Requirements
MD or international equivalent plus accredited residency
Minimum 2 years physician patient care experience
3+ years pharmaceutical industry experience
Experience in pre-approval and post-approval environments