Benefit Risk Evaluation Assessor (Respiratory Health Strategy)

Medicines and Healthcare Products Regulatory Agency

Information:

This job is now closed

Job summary

We are seeking aproactive, confidentand enthusiasticBenefit Risk Evaluation Assessor(Respiratory Health Strategy)to join our group of talentedBenefit Risk Evaluation Assessorsin Safety and Surveillance. The ideal candidate will bewilling to take on a challenge and be resilient.We currently have1 full-time, fixed-term/loan/secondment opportunity until 31/03/2024.

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.

TO BE CONSIDERED FOR THIS ROLE, PLEASE APPLY ON MHRA WEBSITE (http://lhrc1a.rfer.us/MHRAT2w1HT)

ONLY APPLICATIONS MADE ON MHRA WEBSITE WILL BE CONSIDERED

Main duties of the job

This is a new and exciting post to work with internal and external stakeholders to develop a respiratory health strategy for key public health topics such as e-cigarettes/vaping and conduct important safety reviews of emerging issues in the respiratory arena.

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.

About us

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 core objective of the Safety & Surveillance Group is to protect the public from risks associated with medicines and medical devices by:

Ensuring a world class, comprehensive vigilance system that can promptly detect and monitor signals across the product life cycle

Evaluating the benefits and risks of medical products, safety signals, and developing effective and measurable risk mitigation measures

Deploying innovative interventions to reduce the criminal threat

Exploiting data and embracing new technologies to develop the evidence to support our actions and understand their impact

Date posted

31 August 2023

Pay scheme

Other

Salary

£54,088 a year + benefits

Contract

Fixed term

Duration

7 months

Working pattern

Full-time

Reference number

K0015-SCI0H0

Job locations

10 South Colonnade

Canary Wharf

London

E14 4PU


Job description

Job responsibilities

Key responsibilities:

Identification of key issues relating to medicines, medical devices and electronic cigarettes and vaping in the respiratory heath arena, and development of a robust vigilance strategy to monitor these

Work in a matrix style across the agency to develop this, ensuring engagement and involvement from relevant colleagues throughout the process

Be proactive in engaging with all stakeholders including the public, healthcare professionals and companies to develop this strategy

Contribute to and conduct benefit risk evaluation assessments as required for medicines and medical devices in relation to emerging safety concerns utilising a range of data sources

Recommend timely and proportionate regulatory actions to enhance benefit and minimise potential patient safety risks; this may include the development of impactful safety messages

Job description

Job responsibilities

Key responsibilities:

Identification of key issues relating to medicines, medical devices and electronic cigarettes and vaping in the respiratory heath arena, and development of a robust vigilance strategy to monitor these

Work in a matrix style across the agency to develop this, ensuring engagement and involvement from relevant colleagues throughout the process

Be proactive in engaging with all stakeholders including the public, healthcare professionals and companies to develop this strategy

Contribute to and conduct benefit risk evaluation assessments as required for medicines and medical devices in relation to emerging safety concerns utilising a range of data sources

Recommend timely and proportionate regulatory actions to enhance benefit and minimise potential patient safety risks; this may include the development of impactful safety messages

Person Specification

Experience

Essential

  • Our successful candidate will have experience of managing complex projects to agreed milestones, managing conflicting priorities and the work of others and well as an understanding of vigilance and risk management principles for medicines and medical devices and how to apply them. You will have technical knowledge and/or practical experience of a range of medical devices and/or medicine as well as knowledge or experience in conducting benefit risk evaluations of medical devices and or medicines, dealing with complex and sometimes incomplete or missing data. Experience of regulatory affairs and/or respiratory or population health is desirable.
Person Specification

Experience

Essential

  • Our successful candidate will have experience of managing complex projects to agreed milestones, managing conflicting priorities and the work of others and well as an understanding of vigilance and risk management principles for medicines and medical devices and how to apply them. You will have technical knowledge and/or practical experience of a range of medical devices and/or medicine as well as knowledge or experience in conducting benefit risk evaluations of medical devices and or medicines, dealing with complex and sometimes incomplete or missing data. Experience of regulatory affairs and/or respiratory or population health is desirable.

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Employer details

Employer name

Medicines and Healthcare Products Regulatory Agency

Address

10 South Colonnade

Canary Wharf

London

E14 4PU


Employer's website

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency (Opens in a new tab)

Employer details

Employer name

Medicines and Healthcare Products Regulatory Agency

Address

10 South Colonnade

Canary Wharf

London

E14 4PU


Employer's website

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency (Opens in a new tab)

For questions about the job, contact:

Recruitment Team

Careers@mhra.gov.uk

Date posted

31 August 2023

Pay scheme

Other

Salary

£54,088 a year + benefits

Contract

Fixed term

Duration

7 months

Working pattern

Full-time

Reference number

K0015-SCI0H0

Job locations

10 South Colonnade

Canary Wharf

London

E14 4PU


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