The role involves leading cross-functional teams to review safety data and ensure compliance with national and international GxP regulations
Job Summary
The role involves leading cross-functional teams to review safety data and ensure compliance with national and international GxP regulations.
Candidates will be responsible for maintaining the Product Safety Master File (PSMF) and supporting regulatory inspections on behalf of the Qualified Person for Pharmacovigilance.
CSL Behring is a global biotherapeutics leader committed to saving lives through innovative therapies in immunology, hematology, and other therapeutic areas.
Matching Summary
The role involves leading cross-functional teams to review safety data and ensure compliance with national and international GxP regulations.
Skills & Requirements
Must-have
7+ years Pharmacovigilance experience
GxP regulations compliance
ICSR reporting and safety data analysis
MedDRA coding expertise
PSMF maintenance and regulatory inspections
Nice-to-have
Cross-functional team leadership
CAPA management and improvement activities
Impact assessment of evolving legislation
Advanced analytical output development
Mentoring and training junior staff
Key Requirements
Bachelor's or Master's/PhD in life sciences
7+ years PV experience in multinational pharma
Expert knowledge of local/international PV regulations