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
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 incumbent is responsible for setting safety strategy for global projects and ensuring alignment with legal requirements and company standards for Pharmacovigilance tasks.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives, utilizing innovative therapies for conditions in immunology, hematology, and other therapeutic areas.
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 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/biotechnology industry experience
1 year accountability for medical oversight/evaluation