ICSR Quality and Oversight Lead

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 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 .