ICSR Quality and Oversight Lead – CSL
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. Join to apply for the ICSR Quality and Oversight Lead role at CSL.
You will be responsible for the management and oversight of the activities performed by ICSR Quality Control resources, Managed Services and QA & Compliance Oversight team. The incumbent interfaces to support PV Operations strategy and initiatives.
Key Responsibilities
* Accountable for Case Management’s outsourcing strategy to support new acquisitions, integrations, expansion into new regions and company growth.
* Strategic Oversight of Global Case Management Pharmacovigilance vendors as it relates to governance, financials, contracts, reporting, training, and resourcing.
* Strategic Oversight of Global ICSR Quality Assurance activities.
* Oversight of Global ICSR Reconciliation activities.
* Develop and maintain workload metrics related to case volume and resources; adjust workload distribution and vendor resources based on existing or anticipated changes to case volume in order to maintain compliance and overall quality.
* Develop and/or update existing standard operational procedures (SOPs) for relevant functional responsibilities.
* Support audit/inspections and contribute to CAPAs specific to case quality or vendor/resource management, as required.
Skills and Experience Required
* 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.
* Experience working with third parties (e.g., contract service providers) and relationship management.
Qualifications and Education Required
* BS/BA, RN, Pharmacist, or equivalent.
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.
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