Associate Director- Case Management Intake & Submissions
Company: CSL
Location: King of Prussia
Posted on: November 1, 2025
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Job Description:
Your Opportunity: 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. Case Submissions is responsible for
providing accurate implementation of global electronic ICSR
reporting with Regulators, Partners or internal customers.
Additionally, the function 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. The position 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
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 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 is required along with 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. 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 about 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 Inclusion and Belonging | CSL Do work that matters at
CSL!
Keywords: CSL, Lower Merion , Associate Director- Case Management Intake & Submissions, Science, Research & Development , King of Prussia, Pennsylvania
