JOB SUMMARY

We are currently looking for a Senior Benefit Risk Evaluation Assessor to join our Benefit Risk Evaluation II Function 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

A full time, permanent opportunity has arisen in the Gastrointestinal system, Nutrition, Endocrine and Fertility team to lead on complex project work, including in the area of paediatric endocrinology. 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. The post holder should have experience of running challenging projects in public health and have strong stakeholder management skills.

PERSON SPECIFICATION

• Making Effective Decisions: - Use evidence and knowledge to support accurate, expert decisions and advice. Carefully consider alternative options, implications and risks of decisions.
• Delivering at Pace: - Evidence of ability to work in a pressurised, target driven environment, delivering results on time within a range of deadlines maintaining high standards of quality. Evidence of flexibility to adapt to changing priorities and take responsibility for achieving a successful outcome.
• Communicating and Influencing: - 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.
• Working Together: - Actively build and maintain a network of colleagues and contacts to achieve progress on shared objectives. Remain available and approachable to all colleagues and be receptive to new ideas.
  If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!
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SELECTION PROCESS DETAILS

We use the Civil Service Success Profiles to assess our candidates, find out more here.

• Online application form, including questions based on the Behaviour, Experience and Technical Success Profiles. Please ensure all application questions are completed in full; your application may not be considered if any responses are left blank. Our applications are CV blind, and our Hiring Managers will not be able to access your CV when reviewing your application.
• Presentation, to be prepared as part of your interview, with further information being supplied when you reach this stage.
• Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles.

Applicants are assessed on whether they meet any mandatory requirements as well as the necessary skills and experience for the role. Applications are scored based on the competency-based answers provided- ensure you have read these thoroughly and allow sufficient time. You can view the competencies for this role in the job description.

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

KEY RESPONSIBILITIES:

• Monitor the safety of medicines and medical devices
• Conduct evaluations of the balance of benefits and risks of medicinal products and medical devices in use in response to new data and make evidence-based recommendations for action to minimise risk and maximise benefit.
• Ensure patient experience informs benefit risk decisions by identifying and providing opportunities for patient involvement in benefit risk evaluations
• Develop and apply regulatory expertise on risk mitigation and risk management systems, supporting the agency’s objective of safely bringing innovative products to patients as rapidly as possible.
• Provide scientific and/or technical advice and/or conduct assessments of risk management plans in support of new applications for innovative products
• Lead, influence or deliver consistently high-quality critical appraisals/assessment projects for significant safety or risk:benefit issues evaluating all relevant information sources including real-world evidence in accordance with agreed timelines, seeking expert advice where needed and ensuring the patient experience is duly considered
• In accordance with the agreed timetable or to a timeline proportionate to risk, independently and consistently produce and present well written, structured and technically accurate reports, tailored to meet requirements of different stakeholders, which evaluate regulatory options and make recommendations on any need for action and communication
• Take actions to reduce newly identified risks associated with medicines and medical devices, ensuring timely and effective communications to healthcare professionals and patients.
• Develop communications for the public, senior officials or ministers as required and provide scientific, technical and clinical input to ensure regular and timely advice is communicated to healthcare professionals
• As appropriate, lead on the development of accurate, timely and informative Ministerial submissions and responses to Parliamentary Questions, Enquiries, Freedom of Information requests and press enquiries, relating to benefit/risk evaluations sometimes to tight deadlines
• Maintain good working relationships with colleagues and with internal and external stakeholders
• Lead and develop cross portfolio projects identifying and deploying resources and mentoring more junior staff as required to achieve agency patient safety goals
• Develop in depth knowledge of relevant Regulations and regulatory procedures
• Extend skills and knowledge in relevant scientific or professional areas to maintain an influential role