Job summary
We are currently looking for a Expert Benefit Risk Evaluation Assessorto 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.
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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.�
Job description
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.
Respond to other new-emerging safety issues as well as the opportunity to be involved in cross agency projects involving a range of stakeholders.
The role requires experience of working as leading senior assessor in Benefit Risk Evaluation with a proven demonstration of consistently high level of performance in that role including a high throughput of work commensurate with experience and knowledge to meet required deadlines, and experience in relation to the Agency�s systems and processes.
The experience of the successful applicant will be vital in helping to support new members of Benefit Risk Evaluation build their competencies.
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1. Conduct evidence based assessments of balance of benefits and risks of medicines and/or medical devices in response to potential safety signals and/or new data and maintain accurate records of decisions
2. Provide a clinical/scientific opinion to inform benefit risk evaluations as required by other assessors, therapeutic groups and Agency colleagues
3. Take action to reduce newly identified risks associated with medicines and medical devices by updating licences/recommending changes to instructions for use/recommending field safety corrective actions
4. Lead interactions with international regulators, health and social care partners, patients and the public, relevant royal colleges and industry stakeholders
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Person specification
5. Proven experience of working as leading senior assessor in Benefit Risk Evaluation with a proven demonstration of consistently high level of performance
6. Demonstrable experience and skills in coordinating / managing / leading or playing a significant role in assessments that involve sensitive, novel or very complex issues
7. Demonstrable experience of, developing and maintaining relationships with
8. internal and external stakeholders, balancing conflicting demands and agendas
9. Demonstrable experience of representing the Agency at external and/or international for a providing expert opinion ensuring alignment with Agency position and objectives
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If you would like to find out more about this fantastic opportunity,
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Benefits
Alongside your salary of �76,000, Medicines and Healthcare Products Regulatory Agency contributes �22,017 towards you being a member of the Civil Service Defined Benefit Pension scheme.
10. Annual Leave: 25 days annual leave on entry, rising by one day for each completed year of service to a maximum of 30 days and pro-rata for part-time staff. PLUS 8 bank holidays�
11. Privilege Leave: 1 day��
12. Hours of Work: 37 hours (net) per week for full time staff in all geographical locations, including London and pro rata for part-time staff�
13. Occupational Sick Pay (OSP): One month full pay/one month half pay on entry, rising by one month for each completed year of service to a maximum of five months full pay/five months half pay�
14. Mobility: Mobility clause in contracts allowing staff to be mobile across the Civil Service
15. Civil Service Pension Scheme.� Please see the link for further information For enquiries relating to the Civil Service Pension Schemes please contact MyCSP's Pension Service Centre directly on 0300 123 6666�
16. Flexible working to ensure staff maintain a healthy work-life balance�
17. Interest free season ticket loan or bike loan�
18. Employee Assistance Services and access to the Civil Service Benevolent Fund�
19. Eligibility to join the Civil Service Motoring Association (CSMA)
20. Variety of staff and Civil Service clubs�
21. On-going learning and development�
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