Job summary
We are currently looking for a Accredited 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.�
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.
Analyse evidence from a range of sources as well as taking into account stakeholders and patients� views to monitor the benefit: risk balance of medicinal products and devices in clinical use.
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 devices.
Use regulatory expertise on risk management systems, supporting the agency�s objective of safely bringing innovative products to patients as rapidly as possible.
1. Evaluate the benefit-risk balance of medicinal products and medical devices in response to new data and make evidence-based recommendations for action to minimise risk and maximise benefit. Take actions to reduce newly identified risks associated with medicines and medical devices, ensuring timely and effective communications to healthcare professionals and patients.
2. Provide scientific advice and conduct assessments of risk management plans in support of new applications for innovative products
3. Present and discuss your scientific assessments with clinical and scientific expert advisory groups
4. Develop communications for the public, senior officials or ministers as required
Person specification
5. Medically qualified with a degree in medicine and registered to practice with the General Medical Council.
6. Clinical, academic or pharmaceutical medicine experience, including evidence of an up-to-date specialist level of knowledge and evidence of analysis of data and preparation of reports, scientific publications or reviews or manuscripts for regulatory submissions.
7. Sound knowledge and understanding of the relevant regulatory procedures and proven experience of making recommendations and decisions to protect public health and patient safety.
8. Able to produce 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.
9. Ability to communicate with others internal and external to the agency in a clear, honest and enthusiastic way in order to explain complex issues and to build trust.
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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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