Provide 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
Provide 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.
Oversees safety management teams ensuring a thorough and consistent approach to the review of safety data emerging from clinical trials and from the post-marketing environment.
Ensures that the medical and process standards delivered in CSLB are in alignment with safety objectives expected of manufacturers by internal and external stakeholders.
Matching Summary
Provide 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 expertise
safety risk management
pharmacovigilance tasks
signal detection and evaluation
aggregate safety data analysis
cross-functional team representation
Nice-to-have
proactive risk mitigation
medical and scientific environment
inclusion and belonging culture
Key Requirements
MD or international equivalent plus accredited residency
2+ years physician patient care experience
3+ years pharmaceutical/biotechnology industry experience
1+ year medical oversight/evaluation or clinical development experience
Industry experience in designated therapeutic area(s)