JOB SUMMARY

We are currently looking for a Senior Benefit Risk Evaluation Assessor – Vaccine, Infectious Diseases, and Diagnostics to join our Benefit/Risk Evaluation Team II Function within the 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.
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 LOOKING FOR?

Our successful candidate will:

• Have comprehensive experience in critically analysing clinical/scientific information from a range of sources including case reports, registries, clinical trials/investigations, and observational studies, making sound judgements for recommendations to protect patient safety and public health.
• Have in depth knowledge and experience of relevant regulations and procedures applicable medical devices.
• Have previous therapeutic and/or technical experience and expertise relevant to the work of the Vaccines, Infectious Diseases, and Diagnostics Benefit-Risk Evaluation team
• Have excellent interpersonal skills to facilitate team-working/team-leading, consulting and co-operating with colleagues from different disciplines and with variable degrees of expertise
• Share knowledge to improve the capability of the team, benefit risk evaluation group and the wider safety and surveillance function

If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!
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IN THE INSTANCE THAT WE RECEIVE A HIGH NUMBER OF APPLICATIONS, WE WILL HOLD AN INITIAL SIFT BASED ON THE LEAD CRITERIA OF TECHNICAL.

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.

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)
• 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

WHAT’S THE ROLE?

The core purpose of this role is to provide a robust benefit risk assessment of potential safety signals within the Vaccines, Infectious Diseases, and Diagnostics therapeutic area using data from a range of sources and technical, scientific, clinical and regulatory knowledge and/or practical experience. Benefit risk assessors are responsible for engaging with a range of stakeholders including patients and the public to make timely and robust benefit-risk assessments and recommend safety actions and risk mitigations that are outcome focused.
The Benefit risk assessor will help deliver on our ongoing work and increase capacity to respond to new-emerging safety issues. They will have comprehensive medicines regulatory experience as well as professional, technical or scientific expertise in the Vaccines, Infectious Diseases, and Diagnostics therapeutic area.
The experience of the successful applicant will be vital in helping to support new members of the team build their competencies.

KEY RESPONSIBILITIES:

• Lead, influence or deliver consistently high-quality critical appraisals/assessment projects for significant safety or risk:benefit issues 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
• Actively engage with patients and the public, key external stakeholders, government departments, professional bodies and the wider health sector
• Develop communications for the public, senior officials or ministers as required and provide scientific, technical and clinical input to ensure regular and timely advice is communicated to healthcare professionals
• Lead and develop cross portfolio projects identifying and deploying resources and mentoring more junior staff as required to achieve agency patient safety goals

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