ICSR Quality and Oversight Lead

CSLs R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration were 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 Managements 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.

Our Benefits

We encourage you to make your well-being a priority. Its important and so are you. Learn more about how we care at CSL.

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 worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.

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 Behring!