About the job

Job summary

We are currently looking for an Assessor to join our 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.  

We are currently operate 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.

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

 

 

Job description

You will analyse evidence from a range of sources as well as take into account stakeholders and patients’ views to monitor the benefit: risk balance of medical products in clinical use and manage potential safety issues to ensure patient safety is at the centre of all we do. All benefit risk roles require working flexibly to perform and contribute to benefit risk assessments across all medical products as required. You 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.

 

List four key responsibilities of the role:

 

• Lead, influence or deliver consistently high-quality critical appraisals/assessment projects for significant safety or risk: benefit issues for medical products, evaluating all relevant information sources including real-world evidence in accordance with agreed timelines, seeking expert advice where needed and ensuring the patient experience is duly considered in order to make evidence-based recommendations for action to minimise risk and maximise benefit.
• Develop and apply regulatory expertise on risk mitigation and risk management systems, supporting the agency’s objective of safely bringing innovative products to patients as rapidly as possible.
• Provide senior level scientific and technical capacity to inform regulatory decision making, which may include providing technical assessment of medical devices proposed for clinical investigations or assessments of risk management plans in support of new application for medicines.
• Actively engage with patients and the public, key external stakeholders, government departments, professional bodies and the wider health sector to achieve successful implementation of risk mitigation activities for medical products to protect patient safety.

Person specification

Who are we looking for? 

• Making Effective Decisions - Encourage both innovative suggestions and challenge from others, to inform decision making. Analyse and accurately interpret data from various sources to support regulatory decisions. Find the best option by identifying positives, negatives, risks and implications. Present reasonable conclusions from a wide range of complex and sometimes incomplete evidence.
• 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.
• Comprehensive experience in critically analysing clinical, scientific and/or technical information relating to medicines and medical device safety from a range of sources including case reports, clinical or observational studies, make sound judgements for recommendations to protect patient safety and public health.
• Evidence of ability to perform effectively in a pressurised, target driven environment, showing a positive approach to keep the whole team’s efforts focused on the top priorities.
• Proven experience of managing complex projects to agreed milestones, managing conflicting priorities and the work of others
• In depth knowledge and/or experience of applying relevant regulations and procedures for safety and surveillance of medicines and/or medical devices, and experience of both would be desirable.

 

 

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

 

Please note: The job description may not open in some internet browsers. Please use Chrome or Microsoft Edge. If you have any issue viewing the job description, please contact careers@mhra.gov.uk 

Benefits

Alongside your salary of £70,011, Medicines and Healthcare Products Regulatory Agency contributes £20,233 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides.

Things you need to know

Selection process details

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 must be 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 careers@mhra.gov.uk as soon as possible. 

Closing date: 4th July 2024

Shortlisting date: 8th July 2024

Interview date: week commencing 15th July 2024

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 questions, please contact careers@mhra.gov.uk 

 

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

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 complete basic personnel security standard checks.

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 applicant’s 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 eligibility here.

 

Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements. If you have any queries, please contact careers@mhra.gov.uk.

 

In accordance with the Civil Service Commissioners’ Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointment on the basis of merit 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 Mira Mepa, Head of Recruitment and Operations, Mira.Mepa@mhra.gov.uk.  

 

If you are not satisfied with the response you receive, you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk 

 

info@csc.gov.uk 

Civil Service Commission 

Room G/8 

1 Horse Guards Road 

London 

SW1A 2HQ 

Feedback will only be provided if you attend an interview or assessment.

Security

Successful candidates must undergo a criminal record check. People working with government assets must complete baseline personnel security standard (opens in new window) checks.

Nationality requirements

This job is broadly open to the following groups:

• 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.