Associate Director, Case Management Intake & Submissions

CSL Ltd

Multiple Locations
Not specified; not specified; benefits available
Hybrid
10 years clinical trial pharmacovigilance experience
5 years managerial leadership experience
Argus safety database knowledge
CSL Ltd is seeking an Associate Director for Case Management Intake & Submissions within their R&D team, focusing on the oversight of adverse event reporting and regulatory compliance. The role involves collaborating with various stakeholders and managing a team to ensure timely and accurate reporting of safety data

Job Summary

  • This role oversees the Global Adverse Events Inbox and ensures accurate entry of reports into the global safety database.
  • The position requires leading a team to analyze regulatory intelligence and implement updates to reporting requirements for expedited adverse event reporting.
  • CSL offers a hybrid work schedule combining onsite and remote work within an agile team committed to developing life-saving therapies.

Matching Summary

Match Score: 85

CSL Ltd is seeking an Associate Director for Case Management Intake & Submissions within their R&D team, focusing on the oversight of adverse event reporting and regulatory compliance. The role involves collaborating with various stakeholders and managing a team to ensure timely and accurate reporting of safety data.

Salary

Not specified; Not specified; Benefits available

Skills & Requirements

Must-have

  • 10 years clinical trial pharmacovigilance experience
  • 5 years managerial leadership experience
  • Argus Safety database knowledge
  • Global ICSR reporting compliance
  • Regulatory intelligence analysis

Nice-to-have

  • Cross-functional collaboration skills
  • Process improvement initiatives
  • Hybrid work environment adaptability
  • Stakeholder engagement with regulators
  • Team upskilling and development

Key Requirements

  • BS/BA, RN, Pharmacist, or similar degree
  • Minimum 10 years Pharmacovigilance experience
  • Minimum 5 years managerial experience
  • Proficient knowledge of global regulatory rules

Work Rights

Not specified

Tailored Resume

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