Expert Benefit Risk Evaluation Assessor

Job description

Job responsibilities

Role Description

Job Title

Expert Benefit Risk Evaluation Assessor

Pay Grade

SCS1 Fixed term to 30 September 2025

Location

London Canary Wharf with flexible working option

Hours

37 hours per week excluding lunch breaks

Reports to

Head of Benefit Risk Evaluation Team

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.

About the Group and Function

The new Safety and Surveillance Group brings together into a single integrated structure devices and medicines safety expertise with enforcement capabilities. These functions will be supported by our data and evidence generating capabilities complementing our signal generating capabilities produced via the new Safety Connect System.

Medicines and devices have traditionally been regulated separately largely driven by different regulatory processes and ways of working. As science and technology drives increasing understanding of disease, it is also opening new opportunities for treatments with both functions. Product profiles are changing, becoming ever more complex and the boundaries between functions are blurring. These changes provide a unique opportunity to bring functional capabilities together to better address the regulatory challenges of the future. Against this background and the drive to improve treatment availability for patients, safety remains at the heart of our decision making. As such the core objective of the Safety & Surveillance Group is to protect the public from risks associated with medicines and medical devices by:

Ensuring a world class, comprehensive vigilance system that can promptly detect and monitor signals across the product life cycle

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

Deploying innovative interventions to reduce the criminal threat

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

Role Purpose

The core purpose of this role is to provide a robust benefit risk assessment of potential safety signals using data from a range of sources and technical, scientific, clinical and regulatory knowledge and/or practical experience. Expert benefit risk assessors are responsible for engaging with a range of stakeholders including patients and the public to make timely and robust benefit-risk assessments and recommend safety actions and risk mitigations that are outcome focused. There is also the expectation of significant cross Agency working at a high level with Partnerships, Communications and Healthcare Quality and Access to deliver on complex workstreams.

The expert benefit risk assessor will help deliver on our ongoing work and increase capacity to respond to other new-emerging safety issues as well as the opportunity to be involved in the project to implementation of strategies to tackle regulatory inequities in womens health as well as working on high profile issues in this area including in relation to policy and partnerships work.

The experience of the successful applicant will be vital in helping to support new members of the team build their competencies and support across different safety assessment projects.

Safety and Surveillance: Benefit Risk Evaluation Teams

Benefit Risk I

Benefit Risk II

Oncology, Haematology, Thrombotic disease

Musculoskeletal, Trauma and Cosmetic

Immunology, Biocompatibility and non-clinical

Respiratory, Imaging and Critical Care

Vaccines, Infectious diseases and Diagnostics

Cardiovascular and Fluid Management

Skin, Senses, Movement and Pain

Metabolic and Renal systems

Neuro psychiatric conditions, cognition and mental health

Gastrointestinal System, Nutrition, Endocrine and Fertility

We are looking to recruit to the following therapeutic area:

• GI system, Nutrition, Endocrine and Fertility; this is a fixed term position until the end September 2025

Key responsibilities and results areas

Conduct assessments of balance of benefits and risks of medicines and/or medical devices in response to potential safety signals and/or new data

Complete relevant benefit risk evaluation forms and maintain accurate records of decisions as appropriate to underpin regulatory decisions

Make evidence-based recommendations for action to minimise risk and maximise benefit

Provide a clinical/scientific opinion to inform benefit risk evaluations as required by other assessors, therapeutic groups and Agency colleagues

Take action to reduce newly identified risks associated with medicines and medical devices by updating licences/recommending changes to instructions for use/recommending field safety corrective actions

Lead interactions with international regulators, health and social care partners, patients and the public, relevant royal colleges and industry stakeholders

General

Provide clinical/scientific input into the content of timely and effective safety communications to healthcare professionals and patients

Represent the Agency at external meetings, conferences and events

Ensure patient safety is central to everything the Agency does

Assess relevant licensing applications, devices clinical investigation applications, performance studies or Exceptional Use Authorisations as required and applicable in conjunction with SRI

The job description is not intended to be exhaustive and it is likely that duties may be altered from time to time in the light of changing circumstances and after consultation with the postholder.

Person Specification

Experience

Essential

• Candidate will have extensive and in depth knowledge of the regulation of medicines in the UK (UK HMR 2012)
• Highly experienced in analysing and critically appraising clinical/scientific/technical information from a number of sources, including writing reports/papers and presenting at and/or chairing expert committees
• Be able to work collaboratively with customers and delivery partners to manage, monitor and deliver agreed outcomes
• Provides clarity about the action required to achieve results and address unexpected developments
• Influence external partners, stakeholders and customers successfully securing mutually beneficial outcomes

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 details

Employer name

Medicines and Healthcare Products Regulatory Agency

Address

Medicine & Healthcare Regulatory Agency

10 South Colonnade

London

E14 4PU

Employer's website

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency (Opens in a new tab)