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.
The Medical Evaluator provide clinical expertise on all aspects of individual case assessments with special emphasis on ongoing evaluation of safety information during late-stage development and post marketing. You will apply sound medical judgment for analysis and interpretation of clinical safety data. Strong product knowledge is needed for success in the role. The role ensures that the medical aspects of individual cases:
Comply with legal requirements and company standards of the PV (Pharmacovigilance) tasks and responsibilities.
Provide Key information to prevent harm from adverse reactions in humans arising from the use of authorized medicinal products within or outside the terms of the market authorization.
The role interfaces with internal stakeholders, contributes to regulatory reports / submissions / queries
Key Responsibilities
Medical Evaluation and Quality Management: Ensures timely and quality assessment of medical report cases, and answers to queries from Health Authorities according to consistent quality standards.
Regulatory Agency Requests: Responsible for timely and concise responses to Regulatory Agency requests relating to medical evaluation of cases.
Inspections: Ensures regulatory agency inspection findings and internal audit findings relating to the medical assessment processes are addressed and resultant Corrective Action Plans (CAPA plans) are implemented efficiently and effectively in the function
Skills and Experience Required
2 years pharmaceutical / CRO industry experience preferred
2 years of clinical practice experience preferred
Qualifications and Education Required
Advance Science Degree (MD – RN preferred)
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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