Medical Evaluator

CSL Behring; England; On-site; GBP 50,000 - 70,000; Full time

Job summary

A global biotherapeutics leader in the UK is seeking a Medical Evaluator to provide clinical expertise in case assessments with a focus on safety evaluations. The role requires strong analytical skills and a thorough understanding of pharmacovigilance. Candidates should possess an advanced science degree and have at least 2 years of relevant industry experience. This position interfaces with various stakeholders and contributes to regulatory processes ensuring safety in medicinal product usage.

Qualifications

• 2 years pharmaceutical/CRO industry experience.
• 2 years of clinical practice experience.

Responsibilities

• Ensure compliance with legal requirements for pharmacovigilance tasks.
• Provide information to prevent harm from adverse reactions.

Skills

Clinical data analysis

Pharmacovigilance knowledge

Strong product knowledge

Education

Advanced science degree (MD – RN preferred)

Job description

The Medical Evaluator provides 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.

Responsibilities

• Ensure 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, 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. Regulation 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.

Preferred Experience

• 2 years pharmaceutical / CRO industry experience
• 2 years of clinical practice experience

Qualifications and Education Required

• Advanced science degree (MD – RN preferred)

Company Overview

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. 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.