Associate Director, PV Standards
vor 1 Tag
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 RoleMaintain 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 functionsCollaborate with teams (e.g., Safety, Regulatory, Clinical, IT) to embed PV data standards into systems and workflows across the organizationMonitor compliance with PV standards, identifying opportunities for improvement and driving quality enhancementsRepresent us in external standards bodies and industry forums (e.g., ISO IDMP, ICH) to ensure understanding of global standards and industry best practicesSupport audits, inspections, and regulatory submissions by ensuring traceability, documentation, and adherence to PV standardsProvide training and guidance to teams on PV data standards and governance practices, promoting a culture of compliance and continuous improvementQualificationsBachelor's degree in Life Sciences, Pharmacy, Public Health, or a related field10+ years of experience in pharmacovigilance, safety data management, or regulatory affairsKnowledge 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 complianceBENEFITSMedical, Dental Vision401KPaid time Off#LI-HybridAbout CSL BehringCSL 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 and CSL Plasma at .Our Benefits
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