Associate Director- Case Management Intake & Submissions

Your Opportunity

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.

Associate Director – Case Management Intake & Submissions

Case intake is responsible for the oversight of the Global Adverse Events Inbox and all other intake sources within CSL. You will ensure accurate and timely entry of reports into the global safety database by the vendor. Case submissions provide accurate implementation of global electronic ICSR reporting with regulators, partners, or internal customers. The function monitors successful reporting and resolves submission failures to minimize impact on regulatory compliance. You will lead a team responsible for continuous analysis of global documents and regulatory intelligence from interface functions to decide on relevant updates to regulatory and business reporting requirements.

Your Role

Reporting to the Sr. Director, Global Case Management, you’ll:

• 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 acknowledgements.
• 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 collaborate with the WAVES team, IT, and interface functions to ensure accurate and timely changes to expedited reporting requirements are implemented.
• Continuous monitoring and supporting 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 cause of missed reports and take timely action to minimize compliance impact. Liaise with Case Processing Lead and/or Case Management vendor to implement case corrections and training if required.
  • Close collaboration with WAVES team, IT, International Pharmacovigilance, 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 reporting responsibility matrix in close cooperation with GSPV Clinical Trial Liaison, Risk Management, Clinical Operations, and CROs.
  • Review the monthly notifications (Veeva) for study status, 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 templates, ensuring timely study implementation and preventing case processing delays.
• 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 database projects ensuring expedited reporting requirements are correctly addressed. Influence cross‑functions to align at enterprise level solutions.

Your Experience

• BS/BA, RN, Pharmacist, or similar.
• 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.

Our Benefits

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. Learn more at CSL.

We want CSL to reflect the world around us

At 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 about inclusion and belonging at CSL.

Do work that matters at CSL!