Benefit Risk Evaluation Assessor
4 months ago
You will be part of multidisciplinary teams working on a range of safety issues involving medicines or medical devices and will be taking action to prevent risks leading to patient harm
In addition to the competitive salary and options for flexible hybrid working, all positions attract personal and professional development opportunities, we provide a minimum of 5 days training and development per year.
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 implementing a flexible, hybrid way of working, with a minimum of 4 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 8 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. Remote working is potentially available for some specific roles. Please discuss this with the recruiting manager before accepting an appointment.
**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 structure devices and medicines safety expertise with enforcement capabilities. These functions are supported by our data and evidence generating capabilities complementing our signal generating capabilities produced via the new Safety Connect System.
The Musculoskeletal, Trauma and Cosmetic Benefit Risk Evaluation team monitors the safety of medicines and medical devices across these therapy areas. This includes a large focus on medical devices used to orthopaedic use such as hip and knee joint replacements, breast implants and wound care products. The team cover medicines used for cosmetic purposes, musculoskeletal gene therapy and wound care.
**What’s the role?**
The purpose of the Benefit Risk Evaluation is to undertake comprehensive assessments of medicines and medical devices throughout the product lifecycle to ensure that the benefits to patients are favourable and that any residual risks can be mitigated. This specific role will focus on medical device assessments. Benefit risk evaluation works in partnership with a range of diverse stakeholders including patients and the public to ensure that medicines and medical devices are safe and effective for their intended purpose, working to communicate safety information where necessary to prevent potential harm to the end user
The post holder will provide a robust benefit risk assessment of potential safety signals using data from a range of sources and technical, scientific, clinical and regulatory knowledge and/or practical experience. 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
**Key responsibilities**:
- Conduct robust assessments regarding medical devices and medicinal products in relation to emerging safety signals utilising a range of data sources.
- Recommend timely and proportionate regulatory actions to enhance benefit and mitigate potential residual patient safety risks; this may include the development of impactful safety messages.
- Be proactive in engaging with all stakeholders including patients and the public, health care professionals and companies to complete benefit risk evaluation assessments.
- Lead and develop cross portfolio projects identifying and deploying resources and mentoring more junior staff as required to achieve agency patient safety goals.
**Who are we looking for?**
- Have In depth knowledge and/or experience of relevant regulations and procedures applicable to medical devices and sharing knowledge to improve the capability of the various benefit risk evaluation groups and the wider safety and surveillance function
- Have experience of critically analysing complex clinical/scientific/technical information from several sources under pressure and making appropriate recommendations or decisions to protect patient safety/public health even when the evidence is not clear.
- Be able to use interpersonal skills to influence others to take safety seriously and develop and deliver critical improvements and improvements ways of working across benefit risk evaluation, safety and surveillance and the wider Agency.
- Have a degree/postgraduate qualification in a relevant discipline e.g. health, science, regulation or equivalent experience
- You are resilient, recover quickly from setbacks and learn from them.
If you would like to find out more about this fantastic opportunity, pleas
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