Medical Evaluation & Case Processing 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 oversees all areas of single case processing in the global pharmacovigilance database from all sources. This includes ensuring that the vendor performs case processing in accordance with regulatory guidelines PV agreements and the Companys SOPs as well as responding to specific questions or queries about cases. This role develops standards and processes with a focus on global compliance and process optimization.
Oversees Medical Evaluators responsible for medical review of ICSRs.

Key Responsibilities

Oversight of Case Management Processes activities
Oversight of Medical Evaluator role which completes medical review of the following ICSRs:

All serious cases from all sources

Non-serious cases from company-sponsored clinical study if required

Legal ICSRs (serious and non-serious)

Reportable cases of combination products with device issue(s) / malfunction (serious and non-serious)

Non-serious ICSRs are processed by Case Managers and reviewed for correct seriousness on an aggregate basis by Medical Evaluator

Medical review includes:
Review of seriousness listedness and causality assessments
Review of event terms and MedDRA coding
Review of narrative for medical accuracy and consistency
Assessment of the need for Quality Investigations
Generation of medical follow up queries / Targeted Questionnaires
Drive department-wide planning: resource budget and org. strategy
Own case management dashboards and governance scorecards
Prepare for internal and external inspections including coordination of creation of presentations
Lead transformation initiatives (e.g. vendor transitions digital tools)
Monitor regulatory trends and represent PV case management in global initiatives
Coordinate departmental leadership meetings and communication
Pilot innovations (e.g. RPA AI triage tech integration)
Align with Clinical QA Regulatory and Safety Science functions
Coordinate creation and update of SOPs
Retain product and process knowledge

Skills and Education 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

Qualifications and Education Required

BS/BA RN Pharmacist or similar

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!