Associate Director- Case Management Intake

Associate Director- Case Management Intake & Submissions CSL's R&D organisation 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. We are looking for a Associate Director‑ Case Management Intake & Submissions to join our R&D team. Case intake is responsible for the oversight of the Global Adverse Events Inbox and all other intake sources within CSL. You will be responsible for ensuring accurate and timely entry of reports into the global safety database by the vendor. Your Role: Oversee intake and triage of all incoming safety data (spontaneous, literature, partner reports). Monitor outbound submissions to regulators, affiliates, and partners, including E2B tracking and acknowledgments. Coordinate follow‑up activities, ensuring timely and appropriate vendor queries and responses. Provide oversight to ensure global reporting compliance with country‑specific Regulatory and Business requirements related to expedited adverse event reporting. Regularly analyze complex regulatory intelligence underpinning reporting requirements. Complete impact review within defined timelines and closely collaborate with the WAVES team, IT, and interface functions to ensure accurate and timely changes to expedited reporting requirements are implemented to meet regulatory obligations. Continuous monitoring and supporting improvements on electronic submission of Individual Case Safety Reports (ICSRs): Daily monitoring of reporting and reportability of processed cases in Argus Safety database. Analyze underlying cause of missed reports and take timely action to minimize compliance impact. Liaise with the Case Processing Lead and/or Case Management vendor to implement case corrections and training if required. Close collaboration with the WAVES team, IT, International Pharmacovigilance (IPV) & Capability Building and other interface functions to identify opportunities for process improvement. Lead role in liaising with Health Authorities where applicable to resolve issues with E2B submission. Review of interventional clinical trial studies and study‑specific reporting rules: Review study reporting plans and responsibility matrix in close cooperation with the GSPV Clinical Trial Liaison, Risk Management, Clinical Operations and Clinical Research Organizations. Review the monthly notifications (Veeva) for study status including country approval status and update reporting requirements as required. Study setup of post‑marketing studies: Review relevant business documentation (ODCS notifications, IIS information, PVA, etc.), submit and approve Study setup template, ensuring timely study implementation and negating any impact on case processing delay. Development and update of domain‑relevant training documents. Support upskilling of team members to empower accountability to respond to changing business needs. Lead initiatives to develop new processes or optimize current processes related to expedited reporting. Foster cross‑business collaboration to respond to changing business needs. SME for inspections and audits related to database reporting rules and submission oversight. Implement corrective & preventive actions (CAPAs) as necessary. Support for database projects ensuring expedited reporting requirements are correctly addressed. Influence cross functions to align at the enterprise level. Your Experience: BS/BA, RN, Pharmacist, or similar. Minimum of 10 years of Clinical Trial and Post‑marketing Pharmacovigilance (PV) experience with 5 years of managerial/leadership experience. Global pharmacovigilance database knowledge and proficient knowledge of global and local regulatory rules and regulations. Apply now to join a world‑class research organisation innovating globally Please submit your application with your updated resume. We encourage you to make your well‑being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL CSL is a leading global biotechnology company with a dynamic portfolio of life‑saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. #J-18808-Ljbffr