Leading Senior Benefit Risk Evaluation Medical Assessor - £76,000 p.a. + benefits
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We are currently looking for a Leading Senior Benefit Risk Evaluation Medical Assessor to join our Benefit Risk Evaluation 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 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.
The core purpose of Benefit Risk Evaluation is to provide a robust benefit risk assessments of potential safety signals using data from a range of sources and technical, scientific, clinical and regulatory knowledge and/or practical experience. Expert 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.
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.
Contribute to the Agency's wider PV activities and ensuring that safe and effective medicines and medical devices continue to be available to UK patients.
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.
Key responsibilities:
• 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.
• Conduct assessments of the balance of benefits and risks of medicines 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)
• 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
• 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?
Our successful candidate will:
• Degree in Medicine and with a relevant postgraduate qualification. Registered to practice with the General Medical Council.
• Detailed and proven 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 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 Pharmacovigilance 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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We use the Civil Service Success Profiles to assess our candidates, find out more here.
• Online application form, including a statement of suitability, attached as a PDF of no more than 1000 words 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. Our applications are CV blind, and our Hiring Managers will not be able to access your CV when reviewing your application. Please ensure not to include any personal identifying information on your supporting information.
• Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles.
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: 29th September 2024
Shortlisting date: week commencing 30th September 2024
Interview date: week commencing 14th October 2024
Candidates will be contacted within a week of the sift and the interviews completed to inform them of the outcome.
Things you need to know:
- Applicants that meet the criteria based on the Civil Service Success Profiles as listed in the job description are encouraged to submit their application and supporting statement outlining how they meet the key criteria by the closing date.
- If you are successfully shortlisted, you will be contacted within a week of sifting to be invited to an interview. If you are currently a Civil Servant and are successfully offered a post to Senior Civil Servant (SCS) grade, your employment terms and conditions may change. Here ismore information about Senior Civil Servants (SCS) terms and conditions.
- Please attach any additional comments not already covered in your application for the success profile criteria marked as 'Application' on the job description.
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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