Benefit Risk Evaluation Assessor

The Benefit Risk Evaluation Assessor provides robust benefit-risk assessments and reviews safety signals using data from a range of sources, relying on technical, scientific, clinical and regulatory knowledge. The assessor engages with stakeholders including patients, the public, health-care professionals and industry to produce timely, outcome-focused safety recommendations and manage risk mitigations.

Key Responsibilities

• Conduct robust assessments of medical devices and medicinal products related to emerging safety signals using multiple data sources.
• Be proactive in engaging all stakeholders, including patients and the public, health-care professionals and industry, to complete benefit-risk evaluations.
• Recommend timely and proportionate regulatory actions to enhance benefit and mitigate potential residual patient safety risks, including the development of safety messages.
• Work in a matrix style to conduct assessments and, as required, evaluate clinical investigation applications, Exceptional Use Authorisations, Medicinal Product Variations and Risk Management Plans.
• Keep accurate records of assessments and decisions.
• Contribute to and lead projects across the product life cycle to ensure regulatory compliance and assess the impact of regulatory decisions on patient safety and public health.

Behaviours

• Communicating and influencing – communicate straightforwardly, honestly and engagingly, adapting style to maximise understanding and impact, ensuring clarity and checking understanding.
• Making effective decisions – display confidence when making difficult decisions, consult with others to consider stakeholder impacts, gain clear understanding of stakeholder needs and expectations, act to prevent problems and provide solutions.

Experience

• Proven understanding of risk‑management principles to reduce harm.
• Technical knowledge and/or practical experience of a range of medical devices and/or medicines within a therapeutic area.
• Proven experience managing complex projects to agreed milestones, prioritising conflicting priorities and managing the work of others.
• Proven experience conducting benefit‑risk evaluations of medical devices and/or medicines.

Technical Requirements

• Degree or equivalent qualification in a related discipline (e.g. physical or biological sciences, pharmacy, engineering or a relevant healthcare qualification).
• Previous relevant experience in healthcare, medical device or medicinal product manufacturing, regulatory environment, clinical research or equivalent.

Employment Details

This is a full‑time, permanent role based at 10 South Colonnade, Canary Wharf, London, E14 4PU. The role involves a hybrid working model, with a minimum of eight days per month on site, flexible to up to 12 days per month depending on business needs.