Sr. Manager, ICSR Quality
CSL Innovation(2 months ago)
About this role
The Senior Manager, ICSR Quality is accountable for Individual Case Safety Reports (ICSRs) and provides oversight of operational management performed by global case management pharmacovigilance vendors supporting CSL Behring, CSL Seqirus, CSL Vifor and CSL Plasma products. The role supports ICSR quality strategy, reconciliation activities, and contributes to audit/inspection responses. This is a hybrid position combining onsite and remote work.
Required Skills
- Pharmacovigilance
- Vendor Management
- Quality Assurance
- Case Processing
- Reconciliation
- Audit Support
- CAPA Management
- Regulatory Knowledge
- Database Knowledge
- Contract Management
+2 more
Qualifications
- BS/BA
- RN
- Pharmacist
About CSL Innovation
csl.comCSL is a leading global biotechnology company dedicated to creating lifesaving medicines. With a portfolio that includes therapies for rare diseases, immune deficiencies, and vaccines for influenza, CSL's mission is rooted in innovation and public health. The organization comprises three distinct businesses: CSL Behring, focused on plasma-derived therapies; CSL Seqirus, specializing in influenza vaccines; and CSL Vifor, addressing iron deficiency and nephrology. Since its founding in 1916, CSL has been committed to ensuring access to essential treatments for patients in over 100 countries.
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