Associate Director, Case Management Intake & Submissions

Associate Director, Case Management Intake & Submissions Overview Responsible for oversight of global adverse events inbox, intake, and electronic ICSR reporting within CSL’s R&D organization. This hybrid role combines on‑site and remote work. Responsibilities 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. Analyze complex regulatory intelligence underpinning reporting requirements, completing impact reviews within defined timelines and collaborating with WAVES, IT and interface functions to implement changes. Continuous monitoring and support for improvements on electronic submission of Individual Case Safety Reports (ICSRs): Daily monitoring of reporting and reportability of processed cases in the Argus Safety database. Analyze underlying causes of missed reports and take timely action to minimize compliance impact. Engage with Case Processing Lead and/or case management vendor to implement case corrections and training when required. Collaborate with WAVES, IT, International Pharmacovigilance, Capability Building and other interface functions to identify process improvement opportunities. Lead interactions with health authorities to resolve E2B submission issues. Review interventional clinical trial studies and study‑specific reporting rules, including study reporting plans, responsibility matrix and monthly notifications (Veeva) for study status and update reporting requirements. Set up post‑marketing studies: review business documentation, submit and approve study‑setup templates, and ensure timely implementation to avoid processing delays. Develop and update domain‑relevant training documents; support team upskilling. Lead initiatives to develop new processes or optimize current processes related to expedited reporting; foster cross‑business collaboration. Act as SME for inspections and audits related to database reporting rules and submission oversight; implement corrective and preventive actions. Support database projects to ensure expedited reporting requirements are correctly addressed and influence cross‑functions to align enterprise‑level solutions. Qualifications BS/BA, RN, Pharmacist, or similar. Minimum of 10 years of clinical trial and post‑marketing pharmacovigilance experience with at least 5 years of managerial or leadership experience. Knowledge of global pharmacovigilance databases and proficient understanding of global and local regulatory rules and regulations. Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit #J-18808-Ljbffr 6AM City, LLC