Associate Director, Case Management Intake & Submissions

Associate Director, Case Management Intake & Submissions

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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.

We are looking for an Associate Director, Case Management Intake & Submissions to join our R&D team. Under Case Intake, you will oversee the Global Adverse Events Inbox and all other Intake sources within CSL, ensuring accurate and timely entry of reports into the global safety database. Under Case Submissions, you will implement global electronic ICSR reporting with Regulators, Partners, or internal customers, proactively monitor successful reporting, and resolve submission failures to minimize impact to regulatory compliance.

The high business impact of the function requires analysis of varied regulatory sources and engagement with diverse stakeholders and Regulatory Authorities. You will lead a team that continuously analyzes global documents and regulatory intelligence to decide on relevant updates to regulatory and business reporting requirements.

This hybrid role offers a combination of onsite and remote work schedule.

• 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.
• 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, implement changes with>
  
  Continuously monitor and improve electronic submission of Individual Case Safety Reports (ICSRs): daily monitoring of reporting and reportability in Argus Safety database.
• Analyze underlying causes of missed reports and take timely action to minimize compliance impact, liaise with Case Processing Lead or vendor for corrections and training.
• Collaborate with WAVES team, IT, International Pharmacovigilance (IPV) & Capability Building and other interface functions to identify opportunities for process improvement.
• Lead liaison with Health Authorities to resolve issues with E2B submission.
• Review interventional clinical trial studies and study‑specific reporting rules, study reporting plans and responsibility matrices.
• Review monthly notifications (Veeva) for study status and update reporting requirements as required.
• Study setup of post‑marketing studies: submit and approve Study setup template, ensuring timely implementation.
• Develop and update domain‑relevant training documents, support upskilling of team members.
• Lead initiatives to develop new processes or optimize current processes related to expedited reporting.
• SME for inspections and audits related to database reporting rules and submission oversight, implement CAPAs as necessary.
• Support database projects ensuring expedited reporting requirements are correctly addressed.

• 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.

CSL 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…