About the job

Job summary

We are currently looking for a Real World Evidence Specialist to join our Scientific Data and Insight Function within the Safety and Surveillance Group.

This is a full-time opportunity, on a 12 month fixed term contract 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 4 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 8 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.

Job description

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.  

To deliver effectively on our central mission of protecting public health, we need robust vigilance processes that are able to quickly detect, monitor and evaluate safety signals across the product lifecycle, the ability to critically evaluate the benefit/risk balance of signals of concern and design effective risk mitigations, to communicate effectively to patients and the public and a healthcare system able to implement them.  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.

The Agency is committed to supporting innovative approaches to data and evidence generation across the product lifecycle. The forthcoming Data Strategy defines the Agency’s vision for data, digital technologies and real world evidence generation. A key purpose of this role is to ensure the ambitions within the Data Strategy are achieved through the provision of deep subject matter expertise to regulatory and scientific initiatives.

This role will focus on leading and delivering key elements our forthcoming Data Strategy, including the development of scientific advice for innovative biostatistical and epidemiological approaches to real world data and evidence generation, leading the introduction of analytical methodology qualification framework, and inputting to cross-agency data science initiatives.

The role offers an exciting opportunity to be at the forefront of regulatory and scientific aspects of Real World Data and Evidence. The postholder will need to work across the Agency, with partners from across the UK health data ecosystem and key stakeholders.

Key responsibilities of the role:

• As the function’s specialist in Real World Evidence, apply expertise and knowledge in domains such as epidemiology and biostatistics to lead and deliver scientific advice, qualification of methodologies, and cross-Agency data science initiatives.
• Use your expertise in real world data, biostatistics, and epidemiology to evaluate RWE approaches and engage in dialogue with stakeholders to support innovative evidence generation strategies across the lifecycle of medical products.
• Provide expert advice to external stakeholders / requesters, ensuring that the advice adds value to the information that is currently available in the public domain and signposts to MHRA services generating new and ongoing business.
• Develop and build good working relationships across the agency and across related external organisations with a strong appreciation of the wider roles and remits which ensures coordination of activities. Appreciation of different stakeholder views including industry, academia and patients.
• Deliver and support training and other engagement approaches for both internal and external stakeholders.
• Support the publication agenda of the function through writing and developing documents / papers for journals and guidance.

 

Person specification

• Broad and expert experience in quantitative domains related to Real World Data and Evidence Generation in medical product develop and surveillance, including Biostatistics and Epidemiology
• Previous experience in a regulatory, academic, or industry setting with demonstrable contribution to Real World Evidence generation and evaluation for the assessment of the safety and effectiveness of medicines.
• Degree or equivalent qualification in a relevant quantitative discipline such as epidemiology or biostatics, or equivalent professional experience.
• Sound knowledge of global regulations and guidance as related to the role of Real World Data during the clinical development, post-surveillance, and lifecycle management of medicines
• Deep understanding of the role of Real World Data and Real World Evidence in supporting regulatory decisions about the safety and effectiveness of medicines

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 £18,902 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. 
• 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. 

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: 25th April 2024

Shortlisting date: 30th April 2024

Interview date: 9th May 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.