Role Overview
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.
#J-18808-Ljbffr”, “datePosted”: “2026-05-17”, “hiringOrganization”: { “@type”: “Organization”, “name”: “Medicines and Healthcare products Regulatory Agency”, “sameAs”: “https://uk.whatjobs.com/pub_api__cpl__434450217__4861?utm_campaign=publisher&utm_medium=api&utm_source=4861&geoID=33” }, “jobLocation”: { “@type”: “Place”, “address”: { “@type”: “PostalAddress”, “addressLocality”: “London” } } }Role Overview
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.
#J-18808-Ljbffr…