Medical Evaluator

CSL
1 month ago
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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 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.

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