Benefit Risk Assessor - £56,353 p.a. + benefits

We are currently looking for a Benefit Risk Assessor to join our Benefit-Risk Evaluation I function within the Safety and Surveillance group.
This is a full-time opportunity, on a permanent basis. The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU. Please be aware that this role can only be worked in the UK and not overseas.
Government departments and agencies are working towards implementing a minimum 60% attendance in office sites.
We are currently implementing a flexible, hybrid way of working, with a minimum of 8 days per month working on site to enable the collaboration and contact with partners and stakeholders needed to deliver MHRA business. Attendance on site is driven by business needs so depending on the nature of the role, this can flex up to 12 days a month, with the remainder of time worked either remotely or in the office. Some roles will need to be on site more regularly., The Benefit Risk groups I and II within Safety and Surveillance and comprise of 10 therapeutic area multidisciplinary teams. The Vaccines, Infectious Diseases and Diagnostics team (TAU3) monitors the safety and effectiveness of medicines and medical devices used for the detection, management and prophylaxis of infectious diseases. The team therefore monitors and covers the post-market surveillance and risk assessment of:
+ Vaccines for the prevention of infectious disease such as influenza, RSV and COVID-19, vaccines for childhood diseases, and travel/occupational vaccines.
+ Medicines indicated for the treatment of infectious disease such as antibacterials, antifungals, and antivirals.
+ All in vitro diagnostic devices.
+ Protective medical equipment
What’s the role?
Reporting to the Head of Vaccines, Infectious Diseases and Diagnostics a Benefit Risk Assessor is required to conduct assessment of a wide range of data, contributing to the Agency’s wider vigilance activities and ensuring that safe and effective medicines and medical devices continue to be available to UK patients.
+ Input into assessments of the balance of benefits and risks of medicines and medical devices in response to new data.
+ Actively participate in meetings and work programmes to assess safety signals involving medicines and medical devices.
+ Undertake effective matrix working as appropriate across the Benefit-Risk Evaluation functions, the wider Safety and Surveillance Group and Agency lifecycle Groups., Assessment of safety data
+ Proactively monitor the safety of personally allocated products, including innovative medicines and medical devices.
+ Be the lead benefit risk evaluation assessor for safety on Expert Advisory groups and/or short life working groups as appropriate to support effective benefit risk evaluations of potential safety issues
Sharing Knowledge and Development of Self and Colleagues
+ Lead and develop cross portfolio projects identifying and deploying resources and mentoring more junior staff as required to achieve agency patient safety goals.
Contribution to Policy and Procedures including communication with Stakeholders
+ As appropriate, lead on the development of accurate and informative Ministerial submissions, Parliamentary Questions, Enquiries, Freedom of Information requests and press enquiries, relating to benefit/risk evaluations sometimes to tight deadlines., We use the Civil Service Success Profiles to assess our candidates, find out more here.
+ Online application form, including questions based on the Behaviour, Experience and Technical Success Profiles. Please ensure all application questions are completed in full; your application may not be considered if any responses are left blank. Our applications are CV blind, and our Hiring Managers will not be able to access your CV when reviewing your application.
+ Presentation, to be prepared as part of your interview, with further information being supplied when you reach this stage.
+ Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles.
Applicants are assessed on whether they meet any mandatory requirements as well as the necessary skills and experience for the role. Applications are scored based on the competency-based answers provided- ensure you have read these thoroughly and allow sufficient time. You can view the competencies for this role in the job description.
Use of AI in Job Applications
Applicants must ensure that anything submitted is factually accurate and truthful. Plagiarism can include presenting the ideas and experience of others, or generated by artificial intelligence, as your own., + UK nationals
+ nationals of the Republic of Ireland
+ nationals of Commonwealth countries who have the right to work in the UK
+ nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities with settled or pre-settled status under the European Union Settlement Scheme (EUSS) (opens in a new window)
+ nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities who have made a valid application for settled or pre-settled status under the European Union Settlement Scheme (EUSS)
+ individuals with limited leave to remain or indefinite leave to remain who were eligible to apply for EUSS on or before 31 December 2020
+ Turkish nationals, and certain family members of Turkish nationals, who have accrued the right to work in the Civil Service
Further information on nationality requirements (opens in a new window)

Working for the Civil Service
The Civil Service Code (opens in a new window) sets out the standards of behaviour expected of civil servants.
We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission's recruitment principles (opens in a new window).
The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria.
The Civil Service also offers a Redeployment Interview Scheme to civil servants who are at risk of redundancy, and who meet the minimum requirements for the advertised vacancy.

Diversity and Inclusion
The Civil Service is committed to attract, retain and invest in talent wherever it is found. To learn more please see the Civil Service People Plan (opens in a new window) and the Civil Service Diversity and Inclusion Strategy (opens in a new window).

+ Ability to demonstrate “making effective decisions” and “seeing the bigger picture”., + In depth knowledge and/or experience of relevant regulations and procedures applicable to medical devices and sharing knowledge to improve the capability of the various benefit risk evaluation groups and the wider safety and surveillance function.
+ Experience of critically analysing complex clinical/scientific/technical information from a number of sources under pressure and make appropriate recommendations or decisions to protect patient safety/public health even when the evidence is not clear.
+ Writing authoritative reports.
Technical
+ Degree/postgraduate qualification in a relevant discipline e.g. health, science, regulation or equivalent experience.
+ Technical and regulatory knowledge based on previous experience and the ability to acquire new technical knowledge and skills., Successful candidates must undergo a criminal record check.
People working with government assets must complete baseline personnel security standard (opens in new window) checks.

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.
The Safety and Surveillance Group brings together into a single integrated structure, expertise on the safety of all medical products with enforcement capabilities. These functions are supported by the Agency’s data and evidence generating capabilities complementing our signal generating abilities delivered via the common vigilance platform SafetyConnect.
Safety remains at the heart of all our decision making across the product life cycle. The central mission of the Safety & Surveillance portfolio is to protect the public by appropriately identifying, assessing and managing the risks associated with medical products. In every aspect of this work, we harness the best science, technology, information and professional practice to protect patients in new and impactful ways.

Alongside your salary of £56,353, Medicines and Healthcare Products Regulatory Agency contributes £16,325 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides.
+ Annual Leave: 25 days annual leave on entry, rising by one day for each completed year of service to a maximum of 30 days and pro-rata for part-time staff. PLUS 8 bank holidays
+ Privilege Leave: 1 day
+ Hours of Work: 37 hours (net) per week for full time staff in all geographical locations, including London and pro rata for part-time staff
+ Occupational Sick Pay (OSP): One month full pay/one month half pay on entry, rising by one month for each completed year of service to a maximum of five months full pay/five months half pay
+ Mobility: Mobility clause in contracts allowing staff to be mobile across the Civil Service
+ Civil Service Pension Scheme. Please see the link for further information http://www.civilservicepensionscheme.org.uk/ For enquiries relating to the Civil Service Pension Schemes please contact MyCSP's Pension Service Centre directly on
+ Flexible working to ensure staff maintain a healthy work-life balance
+ Interest free season ticket loan or bike loan
+ Employee Assistance Services and access to the Civil Service Benevolent Fund
+ Eligibility to join the Civil Service Motoring Association (CSMA)
+ Variety of staff and Civil Service clubs
+ On-going learning and development