Associate Director, PV Standards & Governance

CSL

12d • Hybrid

About The Position

CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we're building a future-ready team that excels in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Could you be our next Associate Director, PV Standards and Governance? The job is in our King of Prussia, PA or Zurich Switzerland office. This is a hybrid position and is onsite three days a week. You will report to the Head of R&D Data Excellence. You will establish and maintain global standards, policies, and governance frameworks for pharmacovigilance (PV) data and processes. You will ensure compliance, consistency, and quality in safety data management across the R&D organization, supporting regulatory readiness and scientific integrity.

Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Public Health, or a related field
• 10+ years of experience in pharmacovigilance, safety data management, or regulatory affairs
• Knowledge of global PV regulations, data standards (e.g., MedDRA, WHODrug), and safety systems (e.g., Argus, ArisGlobal)
• Experience in data governance, quality management, or standards development, with a focus on regulatory compliance

Responsibilities

• Maintain PV data standards, taxonomies, and controlled vocabularies with global regulatory requirements (e.g., ICH, EMA, FDA)
• Lead governance of PV data and processes, ensuring consistency and standardization across systems, studies, and functions
• Collaborate with teams (e.g., Safety, Regulatory, Clinical, IT) to embed PV data standards into systems and workflows across the organization
• Monitor compliance with PV standards, identifying opportunities for improvement and driving quality enhancements
• Represent us in external standards bodies and industry forums (e.g., ISO IDMP, ICH) to ensure understanding of global standards and industry best practices
• Support audits, inspections, and regulatory submissions by ensuring traceability, documentation, and adherence to PV standards
• Provide training and guidance to teams on PV data standards and governance practices, promoting a culture of compliance and continuous improvement

Benefits

• Medical
• Dental
• Vision
• 401K
• Paid time Off

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees