Hybrid Senior Manager, ICSR Quality

Posted 2 weeks ago

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About the role

  • Senior Manager, ICSR Quality managing Individual Case Safety Reports. Overseeing global pharmacovigilance vendor activities for CSL Behring and related products.

Responsibilities

  • Oversight of Global Case Management Pharmacovigilance vendor(s) as it relates to, governance, financials, contracts, quality and training, and resourcing.
  • Ensure consistency and monitor quality and compliance of end-to-end case processing and other outsourced activities performed by the case management vendor.
  • Oversee case management vendor(s) to manage and resolve emerging issues.
  • Develop and/or maintain/update existing documents for relevant vendor responsibilities.
  • Contributes ICSR quality strategy.
  • Responsible for Global ICSR Reconciliation activities.
  • Support audit/inspections and contribute to CAPAs specific to case quality or vendor/resource management, as required.

Requirements

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

Benefits

  • For more information on CSL benefits visit How CSL Supports Your Well-being | CSL

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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