- 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.
- use your regulatory expertise on risk management systems, supporting the agency�s objective of safely bringing innovative products to patients as rapidly as possible.
- provide scientific advice and conduct assessments of risk management plans in support of new applications for innovative products
- present and discuss your scientific assessments with clinical and scientific expert advisory groups
- critically analyse clinical/scientific information from a range of sources including case reports, clinical trials and observational studies, make sound judgements for recommendations to protect patient safety and public health.
- Use evidence and knowledge to support accurate, expert decisions and advice. Carefully consider alternative options, implications and risks of decisions.
- Apply clinical/scientific perspective to benefit risk evaluations and advise others in the team
- Medically qualified and registered to practice with the General Medical Council
- 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.
- 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�
- Privilege Leave: 1 day��
- 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�
- 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�
- Mobility: Mobility clause in contracts allowing staff to be mobile across the Civil Service
- 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 �
- Flexible working to ensure staff maintain a healthy work-life balance�
- Interest free season ticket loan or bike loan�
- Employee Assistance Services and access to the Civil Service Benevolent Fund�
- Eligibility to join the Civil Service Motoring Association (CSMA)
- Variety of staff and Civil Service clubs�
- On-going learning and development�
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Medical Assessor – Immunology, Biocompatibility and Non-Clinical - London, United Kingdom - UK Civil Service
Description
Job summary
We are currently looking for a Medical Assessor � Immunology, Biocompatibility and Non-Clinical to join our Benefit and Risk 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. �
We are currently operate 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?�
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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.��
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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.�
There are 10 Benefit Risk evaluation teams reflecting Therapeutic Area Teams working across two groups. The purpose of Benefit Risk evaluation is to continually evaluate benefits and risks with medicines and medical devices in use in the GB population and make recommendations for risk minimisation measures to protect public health. There are some pre-market activities including assessing risk management plans for medicines and making recommendations for exceptional use authorisation applications associated with medical devices where there are no suitable CE or UKCA products available.
Job description
The Agency is facing a rapidly evolving external environment involving increasingly complex products and utilisation of these products across an ever more diverse health system.
Reporting to the Head of the Immunology, Biocompatibility and Non-clinical, a Medical 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. They will 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. The post holder will undertake effective matrix working as appropriate across the Benefit-Risk Evaluation functions, the wider Safety and Surveillance Group and Agency life-cycle Groups. The post holder will 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.
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Key responsibilities:�
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Person specification
Our�successful candidate�will:�
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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 �75,000, Medicines and Healthcare Products Regulatory Agency contributes �20,250 towards you being a member of the Civil Service Defined Benefit Pension scheme.
