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 position is responsible for setting safety strategy for global projects and ensuring alignment with internal and external stakeholder expectations including regulators and patients.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives, utilizing advanced technologies to deliver innovative therapies across multiple 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 risk management
Regulatory compliance oversight
DSUR PSUR production
Cross-functional team leadership
Nice-to-have
Proactive safety issue mitigation
Complex medical environment experience
Strong product knowledge application
Key Requirements
MD or international equivalent plus accredited residency
Minimum 2 years physician patient care experience
3+ years pharmaceutical industry experience
1 year accountability for medical oversight or clinical development