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.
The Role
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
Qualifications
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
BENEFITS
Medical, Dental Vision
401K
Paid time Off
#LI-Hybrid
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
