Expert knowledge of fda and international regulations
Experience with regulatory inspections
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CSL Ltd is seeking a Case Processing Oversight Manager who will ensure compliance with pharmacovigilance regulations and oversee the processing of adverse event data. The role requires a strong background in pharmacovigilance within the pharmaceutical industry, alongside experience in regulatory inspections and data management.
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Job Summary
The role ensures compliance with standard operating procedures and regulatory safety requirements across national and international jurisdictions.
Candidates will act as a liaison to develop programs that meet regulatory reporting requirements for adverse events on all marketed products.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies in immunology and hematology.
Matching Summary
Match Score: 75
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CSL Ltd is seeking a Case Processing Oversight Manager who will ensure compliance with pharmacovigilance regulations and oversee the processing of adverse event data. The role requires a strong background in pharmacovigilance within the pharmaceutical industry, alongside experience in regulatory inspections and data management.
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Skills & Requirements
Must-have
5+ years Pharmacovigilance experience
Expert knowledge of FDA and international regulations
Experience with regulatory inspections
Proficiency in complex data set administration
CAPA and SOP development project management
Nice-to-have
Mentoring Medical Evaluators and Case Managers
Signal detection and risk management operations
Medical evaluation of adverse event reports
Literature review and safety data interpretation
Collaboration with data management teams
Key Requirements
Bachelor degree or Master's/PhD in life science discipline
5+ years Pharmacovigilance experience in multinational pharmaceutical industry
Experience with relevant software applications
Experience in project-managing CAPA and SOP development