Benefit Risk Evaluation Assessor - £60,778 p.a. + benefits

Medicines and Healthcare Products Regulatory Agency; City Of London; On-site; GBP 61,000; Full time

Job summary

A UK regulatory agency is seeking a Benefit Risk Evaluation Assessor to provide technical expertise on biological safety. This role involves collaborating with assessors to manage safety signals and advise on regulatory matters. Candidates should possess a degree in life sciences or engineering, and have relevant experience in healthcare or regulatory environments. The position offers a salary of £60,778 per annum and is crucial for patient safety evaluation and risk mitigation efforts.

Benefits

Benefits package

Qualifications

• Relevant experience in healthcare, medical device manufacturing, or regulatory environment.
• Knowledge of biological evaluation standards (ISO 10993 series).
• Understanding of relevant regulatory frameworks regarding biological safety.

Responsibilities

• Participate in meetings to assess biological safety signals.
• Provide technical advice on biological safety to colleagues.
• Review biological safety issues on new safety signals.

Skills

Technical knowledge of biological safety

Healthcare experience

Risk management knowledge

Education

Degree in life sciences, health care, or engineering

Job description

Go back Medicines and Healthcare Products Regulatory Agency

Benefit Risk Evaluation Assessor - £60,778 p.a. + benefits

The closing date is 11 January 2026

****TO APPLY FOR THIS ROLE, PLEASE ENSURE YOU CLICK THE LINK TO APPLY BUTTON (UNDER SUPPORTING LINKS). This will redirect you to the MHRA Website to submit your application. APPLICATIONS SUBMITTED VIA NHS JOBS WILL NOT BE ACCEPTED****

We have an exciting opportunity within the Benefit-Risk Evaluation group, a critical component of Safety and Surveillance. Reporting to the Biosafety, Nonclinical and Emerging Technologies TAU Head, the assessor will provide technical and regulatory expertise on biological safety matters to the Benefit Risk Evaluation Group, the Clinical Investigations Group and across MHRA.

The post holder is required to work collaboratively with other benefit risk assessors across the group to provide expert advice and direction to investigations on biological safety issues. Additionally, the post holder will also lead on the assessment of biological safety for clinical investigations and where appropriate, the development of guidance.

Main duties of the job

Key responsibilities:

• Actively participate in meetings and work programmes to assess and investigate safety signals involving biological safety; effective management of safety issues ensuring relevant assessors are kept up-to-date and quality of work is maintained.
• Provide specialist technical advice and support on biological safety to other colleagues and senior officials to meet divisional business needs and targets.
• Undertake technical reviews of biological safety issues as required on new and emerging safety signals and/or new and emerging data/evidence and make recommendations for actions to protect patients.
• Commitment to continuous development in the area of biological safety and toxicology.

About us

The Medicines and Healthcare products Regulatory Agency enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.

Job responsibilities

The core purpose of Benefit Risk Evaluation is to deliver a robust assessment of potential safety signals using data from a range of sources along with technical, scientific, clinical and regulatory knowledge, and practical experience. The team conducts benefit-risk evaluations for medicines and medical device across a broad spectrum of therapeutic areas to guide actions that protect patient safety. The team is responsible for:

Signal detection of emerging safety issues

Evaluating the benefit risk of signals and developing effective and measurable risk mitigation measures

Using data and embracing new technologies to develop the evidence to support our actions and understand their impact

Person Specification

Experience

• Previous relevant experience gained in healthcare, medical device manufacturing, regulatory environment, or health data science
• Technical knowledge or practical experience of a range of medical devices, including knowledge and experience of standards in biological evaluation (ISO 10993 series) and risk management of medical devices (ISO 14971).
• Knowledge and understanding of the relevant regulatory frameworks, including provisions and relevant guidance related to biological safety.

Qualifications

• Degree or equivalent qualification in life sciences, health care or engineering (such as medical engineering, toxicology material science, or healthcare qualification).

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Employer name

Medicines and Healthcare Products Regulatory Agency