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 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.Oversees Medical Evaluators responsible for medical review of ICSRs.Key ResponsibilitiesOversight of Case Management Processes activitiesOversight of Medical Evaluator role which completes medical review of the following ICSRs:All serious cases from all sourcesNon-serious cases from company-sponsored clinical study, if requiredLegal ICSRs (serious and non-serious)Reportable cases of combination products with device issue(s) / malfunction (serious and non-serious)Non-serious ICSRs are processed by Case Managers and reviewed for correct seriousness on an aggregate basis by Medical EvaluatorMedical review includes:Review of seriousness, listedness and causality assessmentsReview of event terms and MedDRA codingReview of narrative for medical accuracy and consistencyAssessment of the need for Quality InvestigationsGeneration of medical follow up queries / Targeted QuestionnairesDrive department-wide planning: resource, budget, and org. strategyOwn case management dashboards and governance scorecardsPrepare for internal and external inspections including coordination of creation of presentationsLead transformation initiatives (e.g., vendor transitions, digital tools)Monitor regulatory trends and represent PV case management in global initiativesCoordinate departmental leadership meetings and communicationPilot innovations (e.g., RPA, AI triage, tech integration)Align with Clinical, QA, Regulatory, and Safety Science functionsCoordinate creation and update of SOPsRetain product and process knowledgeSkills and Education RequiredMinimum of 10 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience with 5 years of managerial/leadership experienceGlobal pharmacovigilance database knowledge is required along with proficient knowledge of global and local regulatory rules and regulationsQualifications and Education RequiredBS/BA, RN, Pharmacist, or similarOur BenefitsCSL 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 back up 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.Please take the time to review our benefits site to see what’s available to you as a CSL employee.About 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.We want CSL to reflect the world around usAt 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. Learn more Inclusion and Belonging | CSL.Do work that matters at CSL Behring!

Created: 2025-12-01