Expert Benefit Risk Evaluation Assessor

We are currently looking for an Expert Benefit Risk Evaluation Assessorto join our Benefit Risk EvaluationTeam within the Safety & Surveillance group.

This is a fulltime 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.

Who are we

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 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.

Whats the role

Reporting to the relevant Therapeutic Area Unit (TAU) Head the Expert Assessor is required to provide a robust benefit risk assessments of potential safety signals using data from a wide range of sources and technical scientific clinical and regulatory knowledge and/or practical experience.

Candidates should be able to demonstrate the ability to communicate complex issues with clarity and honesty to a wide range of audiences. Expert Benefit Risk assessors are responsible for engaging with a range of stakeholders including patients and the public government departments professional bodies and the wider healthcare sector to make timely and robust benefitrisk assessments and recommend safety actions and risk mitigations that are outcome focused. The post holder will undertake effective matrix working as appropriate across the BenefitRisk Evaluation functions the wider Safety and Surveillance Group and Agency lifecycle Groups.

Key responsibilities:

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

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

Make evidencebased 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

Who are we looking for

Oursuccessful candidatewill have:

• Extensive experience in the benefit risk evaluation of medicines and/or medical devices having demonstrated a consistently high level of performance including a high throughput of work to meet required deadlines
• In depth knowledge of medicines and medical devices regulations
• Detailed knowledge and experience of national and European/International regulations and procedures applicable to medicines and medical devices; evidence of being able to work within the wider government and/or wider healthcare system to achieve a successful outcome
• Proven ability to work independently and effectively to evaluate and provide insight into the most complex assessments including those with new or wideranging issues under pressure using evidence from a number of sources to make appropriate recommendations or decisions in line with the protection of public health

If you would like to find out more about this fantastic opportunity please read our Job Description and Person Specification!

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The selection process:

We use the Civil Service Success Profiles to assess our candidatesfind out more here.

• Online application form including a CVand statement of suitability attached as a PDF demonstrating how you meet the person specification.Please ensure all application questions are completed in full; your application may not be considered if any responses are left blank.Please ensure not to include any personal identifying information on your supporting information.
• Interview which can include questions based on theBehaviour Experience Technical and Strengths Success Profiles.
• Presentation to take place at interview stage with details to follow if you are shortlisted.

Additional Information for Internal Applicants

Eligible applicants should discuss their intention/application and supporting statement with their line manager. Following the discussion the line manager and countersigning manager must complete theManagers Endorsement Form(Word)which isthen submitted by the internal applicant on as an attachment document.It is recommended that you allow your line manager at leastthree working days to complete this to ensure your application can be submitted on time.

To apply please submit an application via the Oracle Recruit system and attach the following documents:

• CV
• Supporting statement detailing how you meet the criteria marked with an A on the person specification
• Managers endorsement form

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.

If you require any disability related adjustments at any point during the process please contact as soon as possible.

Closing date:27 May 2025

Shortlisting date: by 5 June 2025

Interview date:by 20 June 2025

Candidates will be contacted within a week of the sift and the interviews completed to inform them of the outcome.

If you need assistance applying for this role or have any other questionsplease contact

Candidates will be subject to UK immigration requirements as well as Civil Service nationality information on whether you are able to apply is availablehere.

Successful candidates must pass a disclosure and barring security check as well as animal rights and prolife activism checks. People working with government assets must completebasic personnel security standard checks.

Applicants who are successful at interview will be as part of preemployment screening subject to a check on the Internal Fraud Database (IFD). This check will provide information about employees who have been dismissed for fraud or dishonesty offences. This check also applies to employees who resign or otherwise leave before being dismissed for fraud or dishonesty had their employment continued. Any applicants details held on the IFD will be refused employment. A candidate is not eligible to apply for a role within the Civil Service if the application is made within a 5 year period following a dismissal for carrying out internal fraud against government.

Any move to the MHRA from another employer will mean you can no longer access childcare vouchers. This includes moves between government departments. You may however be eligible for other government schemes including TaxFree Childcare. Determine your eligibilityhere.

Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements. If you have any queries please contact.

In accordance with the Civil Service Commissioners Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointmenton the basis ofmerit by a fair and open competition. If you feel your application has not been treated in accordance with the Recruitment Principles and you wish to make a complaint you should firstly contact Florentina Oyelami Head of Talent Acquisition .

If you are not satisfied with the response you receive you can contact the Civil Service Commission at:

Civil Service Commission

Room G/8

1Horse Guards Road

London

SW1A 2HQ