Associate Director, Pv Standards & Governance

CSL Ltd

King of Prussia, PA, USA
Not specified; not specified; medical, dental, vis...
Hybrid (onsite three days a week)
Global pv data standards maintenance
Regulatory compliance with ich ema fda
Meddra whodrug knowledge
CSL Ltd is seeking an Associate Director for Pharmacovigilance (PV) Standards and Governance, focused on establishing global standards and governance frameworks for safety data management. The role requires extensive experience in pharmacovigilance and a strong understanding of global regulatory requirements, with a commitment to compliance and continuous improvement

Job Summary

  • This role involves establishing and maintaining global standards, policies, and governance frameworks for pharmacovigilance data and processes within CSL's R&D organization.
  • The position requires ensuring compliance, consistency, and quality in safety data management while supporting regulatory readiness and scientific integrity.
  • CSL offers a hybrid work model requiring onsite presence three days a week along with comprehensive benefits including medical, dental, vision, and 401K.

Matching Summary

Match Score: 85

CSL Ltd is seeking an Associate Director for Pharmacovigilance (PV) Standards and Governance, focused on establishing global standards and governance frameworks for safety data management. The role requires extensive experience in pharmacovigilance and a strong understanding of global regulatory requirements, with a commitment to compliance and continuous improvement.

Salary

Not specified; Not specified; Medical, Dental, Vision, 401K, Paid time Off

Skills & Requirements

Must-have

  • Global PV data standards maintenance
  • Regulatory compliance with ICH EMA FDA
  • MedDRA WHODrug knowledge
  • Safety systems like Argus ArisGlobal
  • Data governance and quality management

Nice-to-have

  • Experience in external standards bodies
  • Collaboration with cross-functional teams
  • Training and guidance delivery skills
  • Culture of continuous improvement

Key Requirements

  • Bachelor's degree in Life Sciences or related field
  • 10+ years experience in pharmacovigilance or regulatory affairs
  • Knowledge of global PV regulations and data standards

Work Rights

Not specified

Tailored Resume

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