Medical Evaluation & Case Processing Oversight Lead

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. You will oversee 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. Oversees Medical Evaluators responsible for medical review of ICSR. Key Responsibilities Oversight of case management process activities. Oversight of Medical Evaluator role, which completes medical review of: All serious cases from all sources. Non-serious cases from company-sponsored clinical studies, if required. Legal ICSR (serious and non-serious). Reportable cases of combination products with device issue(s)/malfunction (serious and non-serious). Non-serious ICSR processed by Case Managers and reviewed for correct seriousness on an aggregate basis by Medical Evaluator. Medical review tasks: Review of seriousness, listedness, and causality assessments. Review of event terms and MedDRA coding. Review of narrative for medical accuracy and consistency. Assessment of the need for Quality Investigations. Generation of medical follow-up queries / targeted questionnaires. Drive department-wide planning: resource, budget, and organizational strategy. Own case management dashboards and governance scorecards. Prepare for internal and external inspections, including coordination of creation of presentations. Lead transformation initiatives (e.g., vendor transitions, digital tools). Monitor regulatory trends and represent PV case management in global initiatives. Coordinate departmental leadership meetings and communication. Pilot innovations (e.g., RPA, AI triage, tech integration). Align with Clinical, QA, Regulatory, and Safety Science functions. Coordinate creation and update of SOPs. Retain product and process knowledge. Skills and Education Required Minimum of 10 years of Clinical Trial and Post‑marketing Pharmacovigilance experience with 5 years of managerial/leadership experience. Global pharmacovigilance database knowledge is required along with proficient knowledge of global and local regulatory rules and regulations. Qualifications and Education Required BS/BA, RN, Pharmacist, or similar. Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency backup care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. #J-18808-Ljbffr Dormont Manufacturing Co