The Opportunity:
Reporting to the Head of Risk Management, Aggregate Reports & Pharmacovigilance, as the Senior Manager, ICSR Quality, 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) for CSL Behring, CSL Seqirus, CSL Vifor and CSL Plasma products.
The Role:
1. Oversight of Global Case Management Pharmacovigilance vendor(s) as it relates to, governance, financials, contracts, quality and training, and resourcing.
2. Ensure consistency and monitor quality and compliance of end-to-end case processing and other outsourced activities performed by the case management vendor.
3. Oversee case management vendor(s) to manage and resolve emerging issues.
4. Develop and/or maintain/ update existing documents for relevant vendor responsibilities.
5. Contributes ICSR quality strategy.
6. Responsible for Global ICSR Reconciliation activities.
7. Support audit/inspections and contribute to CAPAs specific to case quality or vendor/resource management, as required.
Your Skills & Abilities:
8. BS/BA, RN, Pharmacist, or equivalent.
9. Minimum of 8 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience.
10. Global pharmacovigilance database knowledge is required along with proficient knowledge of global and local regulatory rules and regulations.
11. Experience working with third parties (e.g., contract service providers) and relationship management.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at .
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