Senior Benefit Risk Assessor - £70,011 p.a. + benefits
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We are currently looking for a Senior Benefit Risk Assessor to join our Benefit-Risk Evaluation I 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. 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, 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 Benefit Risk groups I and II within Safety and Surveillance and comprise of 10 therapeutic area multidisciplinary teams. The Vaccines, Infectious Diseases and Diagnostics team (TAU3) monitors the safety and effectiveness of medicines and medical devices used for the detection, management and prophylaxis of infectious diseases. The team therefore monitors and covers the post-market surveillance and risk assessment of:
- Vaccines for the prevention of infectious disease such as influenza, RSV and COVID-19, vaccines for childhood diseases, and travel/occupational vaccines.
- Medicines indicated for the treatment of infectious disease such as antibacterials, antifungals, and antivirals.
- All in vitro diagnostic devices.
- Protective medical equipment.
What's the role?
Reporting to the Head of Vaccines, Infectious Diseases and Diagnostics a Benefit Risk Assessor is required to conduct assessment of a wide range of data, contributing to the Agency's wider vigilance activities and ensuring that safe and effective medicines and medical devices continue to be available to UK patients.
- Involved in the assessment of the regulatory and scientific aspects of the most challenging procedures especially those with innovative or complex issues, contributing to the Agency's wider Pharmacovigilance activities and ensuring that safe and effective medicines and medical devices continue to be available to UK patients.
- Ensure that scientific and technical benefit-risk assessment of potential safety issues takes place promptly and contributes to sound regulatory decisions regarding safety of medicines and performance of devices.
- Undertake effective matrix working as appropriate across the Benefit-Risk Evaluation functions, the wider Safety and Surveillance Group and Agency lifecycle Groups.
Key responsibilities:
Assessment of safety data
- Proactively monitor the safety of personally allocated products, including innovative medicines and medical devices.
- Conduct assessments of the balance of benefits and risks of medicines and medical devices in response to new data, including working with less experienced colleagues and across teams as required, act as the lead assessor, or advising assessor (as appropriate).
Sharing Knowledge and Development of Self and Colleagues
- Provide a leadership role by mentoring or coaching other assessors to enhance their knowledge and contribution in the wider sharing of knowledge.
Contribution to Policy and Procedures including 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.
Who are we looking for?
Behaviours
- Ability to demonstrate "changing and improving" and "managing a quality service".
Experience
- Experience of working consistently at a senior level 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 Pharmacovigilance policy or procedures.
- Proven ability to work independently and effectively to evaluate and provide insight into the most complex assessments including those with new or wide-ranging issues under pressure, using evidence from a number of sources to make appropriate recommendations or decisions in line with the protection of public health.
Technical
• Detailed knowledge and experience of national and European regulations and procedures applicable to pharmacovigilance 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 information internally and externally as appropriate.
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 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 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 careers@mhra.gov.uk as soon as possible.
Closing date: 20th October 2024
Shortlisting date: from 21st October 2024
Interview date: week commencing 4th November 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
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