The role serves as the safety representative in cross-functional development teams and post-marketing product teams while setting global safety strategies
Job Summary
The role serves as the safety representative in cross-functional development teams and post-marketing product teams while setting global safety strategies.
Responsibilities include overseeing safety signal detection, aggregate data analysis, and producing key regulatory documents like DSURs and PSURs.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies in immunology and hematology.
Matching Summary
The role serves as the safety representative in cross-functional development teams and post-marketing product teams while setting global safety strategies.
Skills & Requirements
Must-have
MD or international equivalent with residency
Clinical safety data analysis expertise
Signal detection and risk minimization
DSUR PSUR RMP document production
Regulatory agency interaction experience
Nice-to-have
Cross-functional team leadership skills
Proactive safety issue mitigation
Complex medical environment navigation
Strong product knowledge in therapeutic areas
Key Requirements
Minimum MD degree plus accredited residency
Two years minimum physician patient care experience
Three plus years pharmaceutical industry experience
One year accountability for medical oversight or clinical development