The Global Safety Lead 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 Global Safety Lead 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 role ensures alignment with safety objectives including compliance with legal requirements and company PV standards while preventing harm from adverse reactions and promoting safe use of medicinal products.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives, utilizing innovative therapies for conditions in immunology, hematology, cardiovascular, and metabolic areas.
Matching Summary
The Global Safety Lead 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
MD or international equivalent degree
10 years industry experience
5 years in safety and pharmacovigilance roles
Signal detection and evaluation expertise
Aggregate safety data analysis
DSUR PSUR RMP production oversight
Nice-to-have
Gene therapy safety experience
Hematology knowledge including non-oncology
Competitive landscape awareness
Cross-functional team leadership
Literature search and RWE integration skills
Key Requirements
MD or international equivalent medical degree
Minimum 2 years physician patient care experience
10 years total industry experience required
5 years specific experience in safety and PV roles
Subject matter expertise in scientific data and hematology