Hybrid Senior Manager, ICSR Quality

Posted 43 minutes ago

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About the role

  • Overseeing ICSR Quality and vendor management for Global Case Management at CSL Behring. Ensuring compliance, resolving issues, and supporting audits related to case quality.

Responsibilities

  • Oversight of Global Case Management Pharmacovigilance vendor(s)
  • Ensure consistency and monitor quality and compliance of end-to-end case processing
  • Oversee case management vendor(s) to manage and resolve emerging issues
  • Develop and/or maintain/update existing documents for relevant vendor responsibilities
  • Support audit/inspections and contribute to CAPAs specific to case quality or vendor/resource management.

Requirements

  • BS/BA, RN, Pharmacist, or equivalent
  • Minimum of 8 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience
  • Global pharmacovigilance database knowledge
  • Proficient knowledge of global and local regulatory rules and regulations
  • Experience working with third parties (e.g., contract service providers) and relationship management.

Benefits

  • How CSL Supports Your Well-being | CSL
  • Equal Opportunity Employer

Job title

Senior Manager, ICSR Quality

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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