As the Senior Manager, ICSR Quality, you will be responsible for oversight and control of operational management performed by Global Case Management Pharmacovigilance vendors for CSL products
Job Summary
As the Senior Manager, ICSR Quality, you will be responsible for oversight and control of operational management performed by Global Case Management Pharmacovigilance vendors for CSL products.
CSL Behring is a global biotherapeutics leader focused on innovative therapies using plasma fractionation, recombinant protein technology, and cell and gene therapy.
CSL fosters a culture of inclusion and belonging, celebrating differences to better serve patients and sustain a diverse workforce.
Matching Summary
As the Senior Manager, ICSR Quality, you will be responsible for oversight and control of operational management performed by Global Case Management Pharmacovigilance vendors for CSL products.
Skills & Requirements
Must-have
Global pharmacovigilance database knowledge
Oversight of pharmacovigilance vendors
Quality and compliance monitoring
Case management vendor governance
ICSR quality strategy contribution
Nice-to-have
Hybrid onsite and remote work schedule
Experience with contract service providers
Support audit and inspection processes
Relationship management skills
Inclusion and belonging culture
Key Requirements
Minimum 8 years clinical trial and post-marketing pharmacovigilance experience
BS/BA, RN, Pharmacist, or equivalent degree
Proficient knowledge of global and local regulatory rules