Senior Benefit Risk Evaluation Assessor

We are currently looking for aSenior Benefit Risk Evaluation Assessor to join ourBenefit Risk Evaluation II Functionwithin theSafety & Surveillancegroup.

This is a fulltimeopportunity 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 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.

Whats the role

A full time permanent opportunity has arisen in the Gastrointestinal system Nutrition Endocrine and Fertility team to lead on complex project work including in the area of paediatric Agency is facing a rapidly evolving external environment involving increasingly complex products and utilisation of these products across an ever more diverse health system. The post holder should have experience of running challenging projects in public health and have strong stakeholder management skills.

Key responsibilities:

• Monitor the safety of medicines and medical devices
• Conduct evaluations of the balance of benefits and risks of medicinal products and medical devices in use in response to new data and make evidencebased recommendations for action to minimise risk and maximise benefit.
• Ensure patient experience informs benefit risk decisions by identifying and providing opportunities for patient involvement in benefit risk evaluations
• Develop and apply regulatory expertise on risk mitigation and risk management systems supporting the agencys objective of safely bringing innovative products to patients as rapidly as possible.
• Provide scientific and/or technical advice and/or conduct assessments of risk management plans in support of new applications for innovative products
• Lead influence or deliver consistently highquality critical appraisals/assessment projects for significant safety or risk:benefit issues evaluating all relevant information sources including realworld evidence in accordance with agreed timelines seeking expert advice where needed and ensuring the patient experience is duly considered
• In accordance with the agreed timetable or to a timeline proportionate to risk independently and consistently produce and present well written structured and technically accurate reports tailored to meet requirements of different stakeholders which evaluate regulatory options and make recommendations on any need for action and communication
• Take actions to reduce newly identified risks associated with medicines and medical devices ensuring timely and effective communications to healthcare professionals and patients.
• Develop communications for the public senior officials or ministers as requiredand provide scientific technical and clinical input to ensure regular and timely advice is communicated to healthcare professionals
• As appropriate lead on the development of accurate timely and informative Ministerial submissions and responses to Parliamentary Questions Enquiries Freedom of Information requests and press enquiries relating to benefit/risk evaluations sometimes to tight deadlines
• Maintain good working relationships with colleagues and with internal and external stakeholders
• Lead and develop cross portfolio projects identifying and deploying resources and mentoring more junior staff as required to achieve agency patient safety goals
• Develop in depth knowledge of relevant Regulations and regulatory procedures
• Extend skills and knowledge in relevant scientific or professional areas to maintain an influential role

Who are we looking for

Oursuccessful candidatewill:

• Making Effective Decisions: Use evidence and knowledge to support accurate expert decisions and advice. Carefully consider alternative options implications and risks of decisions.
• Delivering at Pace: Evidence ofability to work in a pressurised target driven environment delivering results on time within a range of deadlines maintaining high standards of quality. Evidence of flexibility to adapt to changing priorities and take responsibility for achieving a successful outcome.
• Communicating and Influencing: Ability to communicate with others internal and external to the agency in a clear honest and enthusiastic way in order to explain complex issues and to build trust.
• Working Together: Actively build and maintain a network of colleagues and contacts to achieve progress on shared objectives. Remain available and approachable to all colleagues and be receptive to new ideas.

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 questions based on theBehaviour 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 theBehaviour 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 competencybased answers provided ensure you have read these thoroughly and allowsufficienttime. 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.

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

Closing date:15^th May 2025

Shortlisting date: from 16th May 2025

Interview date: from 19th May 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 OleylamiHead 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