Medical Evaluator

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.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 / queriesKey ResponsibilitiesMedical 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 functionSkills and Experience Required2 years pharmaceutical / CRO industry experience preferred2 years of clinical practice experience preferredQualifications and Education RequiredAdvance Science Degree (MD RN preferred)Our BenefitsWe 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 BehringCSL 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 usAt 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 CSLDo work that matters at CSL Behring Key Skills Interventional Radiology,ASP.NET,Informatica,Information Technology Sales,Instrument Maintenance Employment Type : Full-Time Experience: years Vacancy: 1