Reporting to the Head of Risk Management, Aggregate Reports & Pharmacovigilance, you will have Individual Case Safety Reports (ICSRs) accountability and you will be responsible for the oversight and control of the operational management and activities performed by the Global Case Management Pharmacovigilance vendor(s)
Job Summary
Reporting to the Head of Risk Management, Aggregate Reports & Pharmacovigilance, you will have Individual Case Safety Reports (ICSRs) accountability and you will be responsible for the oversight and control of the operational management and activities performed by the Global Case Management Pharmacovigilance vendor(s).
Ensure consistency and monitor quality and compliance of end-to-end case processing and other outsourced activities performed by the case management vendor.
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out.
Matching Summary
Reporting to the Head of Risk Management, Aggregate Reports & Pharmacovigilance, you will have Individual Case Safety Reports (ICSRs) accountability and you will be responsible for the oversight and control of the operational management and activities performed by the Global Case Management Pharmacovigilance vendor(s).
Skills & Requirements
Must-have
Global Case Management Oversight
ICSR Quality Strategy
Vendor Governance and Quality
Pharmacovigilance Vendor Management
Global ICSR Reconciliation
Nice-to-have
Culture of curiosity and empathy
Celebrating differences
Patient-focused innovation
Key Requirements
BS/BA, RN, Pharmacist, or equivalent
Minimum of 8 years PV experience
Global pharmacovigilance database knowledge
Proficient knowledge of global and local regulatory rules