The role involves managing day-to-day global safety operations across Immunome's clinical stage oncology programs and commercial products
Job Summary
The role involves managing day-to-day global safety operations across Immunome's clinical stage oncology programs and commercial products.
Candidates must oversee safety case processing activities performed by external vendors including intake, assessment, follow-up, and regulatory submissions.
The position requires maintaining inspection-ready safety systems and ensuring timely compliance with FDA, EMA, ICH, and CIOMS regulations.
Matching Summary
The role involves managing day-to-day global safety operations across Immunome's clinical stage oncology programs and commercial products.
Skills & Requirements
Must-have
Pharmacovigilance operations management
Safety case processing oversight
FDA EMA ICH CIOMS regulatory compliance
External vendor and CRO management
MedDRA coding validation
Oncology clinical trial safety support
Nice-to-have
Adaptable to growing organization needs
Cross-functional communication skills
Inspection ready safety systems experience
Operational excellence drive
Key Requirements
Experience in Pharmacovigilance operations
Knowledge of global regulatory requirements (FDA/EMA)