Safety Scientist-£33,502 p.a. + benefits London, England
Job description
We are currently looking for a Safety Scientist to join our Clinical Investigations and Trials Team within the Science, Research and Innovation group.
This is a full-time opportunity, on a permanent basis (start date late November 2023). 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 Scientific Research and Innovation Group delivers public health impact, world-leading research innovation, and a unique proposition via an ambitious Science Strategy which will balance innovation against sustainability and affordability. It is divided into 6 sub-Groups, Innovation Accelerator, Clinical Investigations and Trials (CIT), Research and Development, Standards Lifecycle, Control Testing and Quality Assurance and Health & Safety.
You will be working within the Clinical Investigations and Trials Unit and be primarily responsible for the processing of annual and expedited safety reports and ensuring that accurate and up-to-date safety information is available to the Senior Clinical Safety Scientist, CIT assessors and drug safety teams in other Agency Groups.
What’s the role?
As Safety Scientist, you will work alongside and support the Senior Safety Manager in the coordination of the assessment of all UK relevant clinical trial safety data. You will assist in the generation and presentation of safety metrics on clinical trial safety data, respond to enquiries within deliverable timelines, as well as conducting routine compliance of safety reports. This role will also offer the opportunity for potential safety oversight of devices clinical investigations.
Key responsibilities:
Ensures that all safety reports are entered on to the relevant database(s), including internal databases, within statutory timelines. Supports the processing of electronic safety reports and related queries.
Contributes to maintaining the safety of patients and trial integrity through monitoring of Urgent Safety Measure notifications, liaising with CIT Assessors throughout and taking appropriate action.
Contributes to reviews into potential safety alerts through use of various analytical applications, liaising with CIT Assessors, as well as across the Agency.
Contributes to activities that will support the UK regulatory landscape for clinical trial safety.
Who are we looking for?
Our successful candidate will:
Proven ability to take initiative and demonstrate an analytical approach towards work and process improvements.
Demonstrate strong planning and organisational skills with proven ability to effectively manage changing priorities. Act promptly to reassess workloads and priorities when there are conflicting demands, in order to maintain performance.
Confidence and ability to work in a pressurised, target driven environment, whilst maintaining high standards of quality and accuracy. Identify risks and resolve issues efficiently.
Excellent interpersonal skills and a proven ability to build relationships with a range of stakeholders both internal and external.
Graduate with Life Science or other relevant degree, or appropriate work experience in the pharmaceutical, medical sector and/or regulatory sectors or equivalent experience.
If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!
Please note: The job description may not open in some internet browsers. Please use Chrome or Microsoft Edge. If you have any issue viewing the job description, please contact [email protected]
The selection process:
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.
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.
If you require any disability related adjustments at any point during the process, please contact [email protected] as soon as possible.
Closing date: 14/08
Interview date: w.c. 04/09
If you need assistance applying for this role or have any other questions, please contact [email protected]
Candidates will be subject to UK immigration requirements as well as Civil Service nationality rules. Further information on whether you are able to apply is available here.
Successful candidates must pass a disclosure and barring security check as well as animal rights and pro-life activism checks. People working with government assets must complete basic personnel security standard checks.
Applicants who are successful at interview will be, as part of pre-employment screening subject to a check on the Internal Fraud Database (IFD). This check will provide information about employees who have been dismissed for fraud or dishonesty offences. This check also applies to employees who resign or otherwise leave before being dismissed for fraud or dishonesty had their employment continued. Any applicant’s details held on the IFD will be refused employment. A candidate is not eligible to apply for a role within the Civil Service if the application is made within a 5 year period following a dismissal for carrying out internal fraud against government.
Any move to the MHRA from another employer will mean you can no longer access childcare vouchers. This includes moves between government departments. You may however be eligible for other government schemes, including Tax-Free Childcare. Determine your eligibility here.
Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements. If you have any queries, please contact [email protected].
In accordance with the Civil Service Commissioners’ Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointment on the basis of merit by a fair and open competition. If you feel your application has not been treated in accordance with the Recruitment Principles and you wish to make a complaint, you should firstly contact Mira Mepa, Head of Recruitment and Operations, [email protected].
If you are not satisfied with the response you receive, you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk
Civil Service Commission
Room G/8
1 Horse Guards Road
London
SW1A 2HQ
