The 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.
We are looking for a Associate Director, Case Management Intake & Submissions to join our R&D team. Under Case Intake, you will be responsible for the oversight of the Global Adverse Events Inbox, and all other Intake sources within CSL. You will also be responsible for ensuring accurate and timely entry of reports into the global safety database by the vendor. Under Case Submissions, you will be responsible for providing accurate implementation of global electronic ICSR reporting with Regulators, Partners or internal customers. Additionally, you will proactively monitor successful reporting and resolve submission failures to minimize impact to regulatory compliance. The Case Submission aspect of the function has a high business impact as reporting compliance is potentially affected and will require ability to analyze varied regulatory sources and engage readily with diverse stakeholders and Regulatory Authorities. 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.
This is a hybrid role, which offers a combination of an onsite and remote work schedule. #LI-hybrid
The Role:
Reporting to the Sr. Director, Global Case Management, you will:
- 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. Completion of impact review within defined timelines and closely collaborate with WAVES team, IT and interface functions to ensure accurate and timely changes to expedited reporting requirements are adequately 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 Case Processing Lead and/or Case Management vendor to implement case corrections and training if required. · Close collaboration with WAVES team, IT, International Pharmacovigilance (IPV) & Capability Building and other interface functions to identify opportunities of 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 of study reporting plans and reporting responsibility matrix in close cooperation with GSPV Clinical Trial Liason, 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 to 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 enterprise level solutions.
Your Skills and Abilities:
- 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 is required along with proficient knowledge of global and local regulatory rules and regulations.
About CSL Behring
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 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.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
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.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
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 https://www.csl.com/accessibility-statement.
