ICSR Quality and Oversight Lead

CSL
Maidenhead
3 months ago
Applications closed

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Sr. Manager, ICSR Quality

Associate Director, Case Management Intake & Submissions

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.

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 is required along with 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.


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.

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