JOB SUMMARY

We are currently looking for an Expert Benefit Risk Evaluation Assessor to join our Benefit Risk Evaluation Team within the Safety & 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.

JOB DESCRIPTION

•Conduct assessments of benefits and risks of medicines and/or medical devices in response to potential safety signals and/or new data
•Complete relevant benefit risk evaluations and maintain accurate records of decisions as appropriate to underpin regulatory decisions
•Make evidence-based recommendations for action to minimise risk and maximise benefit
•Provide a clinical/scientific opinion to inform benefit risk evaluations as required by other assessors, therapeutic groups and Agency colleagues
•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

PERSON SPECIFICATION

Our successful candidate will have:

• Extensive experience in the benefit risk evaluation of medicines and/or medical devices having demonstrated a consistently high level of performance including a high throughput of work to meet required deadlines
• In depth knowledge of medicines and medical devices regulations
• Detailed knowledge and experience of national and European/International regulations and procedures applicable to medicines and medical devices; evidence of being able to work within the wider government and/or wider healthcare system to achieve a successful outcome
• Proven ability to work independently and effectively to evaluate and provide insight into the most complex assessments including those with new or wide-ranging issues under pressure, using evidence from a number of sources to make appropriate recommendations or decisions in line with the protection of public health

If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!
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NATIONALITY REQUIREMENTS

This job is broadly open to the following groups:

• UK nationals
• nationals of the Republic of Ireland
• nationals of Commonwealth countries who have the right to work in the UK
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities with settled or pre-settled status under the European Union Settlement Scheme (EUSS)
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities who have made a valid application for settled or pre-settled status under the European Union Settlement Scheme (EUSS)
• individuals with limited leave to remain or indefinite leave to remain who were eligible to apply for EUSS on or before 31 December 2020
• Turkish nationals, and certain family members of Turkish nationals, who have accrued the right to work in the Civil Service

Further information on nationality requirements

WHAT’S THE ROLE?

Reporting to the relevant Therapeutic Area Unit (TAU) Head, the Expert Assessor is required to provide a robust benefit risk assessments of potential safety signals using data from a wide range of sources and technical, scientific, clinical and regulatory knowledge and/or practical experience.
Candidates should be able to demonstrate the ability to communicate complex issues with clarity and honesty to a wide range of audiences. Expert Benefit Risk assessors are responsible for engaging with a range of stakeholders including patients and the public, government departments, professional bodies and the wider healthcare sector to make timely and robust benefit-risk assessments and recommend safety actions and risk mitigations that are outcome focused. 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.