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Job Description

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.

\n\n You will oversees all areas of single case processing in the global pharmacovigilance database from all sources. This includes ensuring that the vendor performs case processing in accordance with regulatory guidelines, PV agreements, and the Company's SOPs, as well as responding to specific questions or queries about cases. This role develops standards and processes, with a focus on global compliance and process optimization.

\n Oversees Medical Evaluators responsible for medical review of ICSRs. \n\n Oversight of Medical Evaluator role which completes medical review of the following ICSRs: \n Legal ICSRs (serious and non-serious)\n Non-serious ICSRs are processed by Case Managers and reviewed for correct seriousness on an aggregate basis by Medical Evaluator \n Medical review includes: \n Review of event terms and MedDRA coding \n Review of narrative for medical accuracy and consistency \n Assessment of the need for Quality Investigations \n of medical follow up queries / Targeted Questionnaires \n Drive department-wide planning: resource, budget, and org. Prepare for internal and external inspections including coordination of creation of presentations \n Lead transformation initiatives (e.g., vendor transitions, digital tools)\n Monitor regulatory trends and represent PV case management in global initiatives \n Align with Clinical, QA, Regulatory, and Safety Science functions \n Global pharmacovigilance database knowledge is required along with proficient knowledge of global and local regulatory rules and regulations \n\n 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.

\n\n CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. 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.

To learn more about inclusion and belonging visit \n \n If you are an individual with a and need a reasonable accommodation for any part of the application process, please visit .

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