CDF Leading Senior Benefit Risk Evaluation Medical Assessor

We are currently looking for aLeading Senior Benefit Risk Evaluation Medical Assessorto join our Benefit/Risk Evaluation Team within the Safety & 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.

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.

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 medicines and devices for which signals or other safety concerns emerge and developing effective and measurable risk mitigation measures

• Ensuring patients and other stakeholders are involved in the regulatory processes and appropriate messages are issued for patients and stakeholders following regulatory decisions

• 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

The Benefit Risk groups I and II within Safety and Surveillance comprise 10 teams covering the following the therapeutic areas:

Whats the role

Reporting to the relevant Head in Benefit Risk groups a Leading Senior Medical Assessor is required to provide a lead across the groups in the assessment of the regulatory and scientific aspects of the most challenging procedures especially those with innovative or complex issues contributing to the Agencys wider PV activities and ensuring that safe and effective medicines and medical devices continue to be available to UK patients. The post holder will undertake effective matrix working as appropriate across the Benefit-Risk Evaluation functions the wider Safety and Surveillance Group and Agency life-cycle Groups. The post holder will ensure that scientific technical and clinical benefit-risk assessment of potential safety issues takes place promptly and contributes to sound regulatory decisions regarding safety of medicines and performance of devices.

The role requires experience of working as a senior medical assessor in Benefit Risk Evaluation with a proven demonstration of consistently high level of performance in that role including a high throughput of work commensurate with experience and knowledge to meet required deadlines and experience in relation to the Agencys systems and processes.

The Leading Senior Medical Assessor will be recognized as having extensive regulatory experience and understanding of the operation of all relevant national and international regulations as well as professional or scientific expertise in their discipline. This post holder will participate in complex engagement and partnership work with patients and the public key external stakeholders government departments professional bodies and the wider health sector. They will make a significant contribution to the Safety & Surveillance Groups and Agency through wider activities associated with their work working across teams as necessary.

Key responsibilities:

1. Assessment of safety data

• Proactively monitor the safety of personally allocated medicinal products including innovative medicines and medical devices.

• Support innovation and patient access by providing advice to applicants on risk management activities and assessing risk management plans for relevant licensing applications

• Ensure effective risk management including through evaluation of effectiveness of risk minimisation measures where appropriate

• Conduct assessments of the balance of benefits and risks of medicines in response to new data includingworking with less experienced colleagues and across teams as required act as the lead assessor or advising assessor (as appropriate)

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

• Take actions to reduce newly identified risks associated with medicines by ensuring licences are updated supported by timely and effective communications to healthcare professionals and patients

• Prepare and present objective assessments or other scientific papers to internal and external expert advisory bodies and committees

• Take a lead in providing influential reliable timely and appropriate scientific and regulatory advice to companies at meetings and in writing especially in cases where there is no relevant regulatory guidance

• Manage own workload working in conjunction with service coordinators and other assessors to meet Group and Agency deadlines and targets.

2. Sharing Knowledge and Development of Self and Colleagues

• Maintain a personal record of Continuing Professional Development activities and participates fully in medical appraisal for revalidation.

• Provide a leadership role by mentoring or coaching other assessors and senior assessors to enhance their knowledge and contribution in the wider sharing of knowledge

• Provide ad hoc advice to senior managers other parts of DHSC other governmental departments and bodies and ministers.

• Extend skills and knowledge in relevant scientific or professional areas to act as a resource for colleagues

1. Contribution to Policy and Proceduresincluding communication with Stakeholders

• Alongside experts and managers initiate lead or influence guidelines procedures or policy and practice nationally or otherwise that are beneficial for protection of public health

• Make individual contributions to representational or professional activities inside and outside the Agency

• Maintain good working relationships with colleagues and with internal and external stakeholders

• Deal effectively with official correspondence to agreed timelines

• Identify resource needs to support initiatives or policy changes recommended

Who are we looking for

Oursuccessful candidatewill have the following:

• A degree in Medicine and with a relevant postgraduate qualification. Registered to practice with the General Medical Council

• Detailed and proven knowledge and experience of regulations and procedures applicable to pharmacovigilance vigilance/post-market surveillance for medical products and their own discipline; and evidence of being able to work within the wider governmental to achieve successful outcomes

• Highly developed written and verbal communication skills used in a range of circumstances and appropriate to the target audience to proactively influence internal and external issues and disseminate complex information internally and externally as appropriate.

• Experience of working as a senior medical assessor having demonstrated a consistently high level of performance in that role including a high throughput of work commensurate with experience and knowledge to meet required deadlines.

• Experience of having led or significantly contributed to the development of internal or external regulatory and vigilance policy or procedures

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 up to 1500 words 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.

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:07 November 2025

Shortlisting date: Completed by 21 November 2025

Interview date:Completed by 05 December 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 pro-life activism checks. People working with government assets must completebasic personnel security standard checks.

Certain roles within the MHRA will require post holders to have vaccinations and in some circumstances routine health surveillance. These roles include:

• Laboratory-based roles working directly with known pathogens

• Maintenance roles particularly those required to work in laboratory settings

• Roles that involve visiting other establishments where vaccination is required

• Roles required to travel overseas where specific vaccination may be required.

Applicants who are successful at interview will be as part of pre-employment 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 Tax-Free 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