Pharmaceutical Assessor in the Quality Team United Kingdom
Job description
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Salary
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Contract type
Apprenticeship
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Type of role
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Contents
Location
About the job
Benefits
Things you need to know
Apply and further information
Location
About the job
Job summary
This job puts you at heart of authorising veterinary medicines for the UK market and plays a major role in assuring the quality and hence the safety and efficacy of these medicines. You will be a member of the Quality team, one of three specialist teams within the Pharmaceuticals Section, which is in turn part of the Authorisations Division.
The main role of the Quality team is to assess quality data submitted by companies in support of their applications for marketing authorisations for veterinary medicines, and applications to vary or renew these authorisations. The Quality team also has a significant role in the delivery of the VMD’s regulatory science strategy, development of regulatory and scientific guidelines aimed at the pharmaceutical industry and supporting the delivery of VMD`s international activities, which includes training other veterinary medicine regulators.
Job description
The main role of the team is:
- to assess quality data submitted by companies in support of their applications for new marketing authorisations for veterinary medicines
- to consider applications to renew or vary existing authorisations
- to consider applications to conduct clinical trials and to deal with applications for feed additive authorisations
- to support the delivery of the VMD’s International strategy
You will:
- scientifically assess pharmaceutical data submitted by companies in support of their applications to market veterinary pharmaceutical products - these applications will encompass new marketing authorisations, as well as variations and renewals to current marketing authorisations
- undertake a detailed evaluation of pharmaceutical data and, in liaison with other assessors, formulate a recommendation to accept or refuse the application, based on the benefits and risks you identify during the assessment
- produce a written report that forms the quality section of the overall VMD assessment report for the application
- peer review assessment reports prepared by other Quality assessors
- communicate your assessments clearly to internal decision-making groups – to enable them to decide whether the data satisfy regulatory requirements and to decide on a course of action
- deal with enquiries and represent the Quality team at meetings with internal and external stakeholders
- develop and maintain a thorough working knowledge of your own specialism and of the relevant legislation and guidelines
- support the delivery of the international strategic objectives, including delivery of training and other projects
- collaborate with members of the Authorisations Division to achieve the Division’s overall objectives and
- contribute to wider VMD initiatives, such as training and education, and our publicity programme.
Person specification
Applicants must have the following experience and qualifications :
Experience
Experience of pharmaceutical practice within the human or veterinary pharmaceutical (or closely related) industry and/or, - of authorisation processes for medicinal products
IT Skills
You must be proficient in the use of Microsoft Office packages, particularly Word, Excel , PowerPoint and Outlook. You must use the internet effectively and have the aptitude to learn how to use the VMD’s bespoke IT systems
Qualifications
Behaviours
We'll assess you against these behaviours during the selection process:
- Working Together
- Communicating and Influencing
- Making Effective Decisions
- Developing Self and Others
Benefits
- Learning and development tailored to your role
- An environment with flexible working options
- A culture encouraging inclusion and diversity
- A Civil Service pension with an average employer contribution of 27%
- Free onsite parking
- Free eyesight test
- Onsite gym
- Access to a prayer room
Things you need to know
Selection process details
Application Process
As part of the application process, you will be asked to complete a CV and Personal Statement, and Behaviour Statements. The CV will ask for your job history, qualifications and past skills and experience.
Your Personal Statement should be no more than 750 words and should outline how your skills and experience are relevant to the role.
When giving examples of Behaviours please use the Situation, Task, Action, Result (STAR) format. Behaviours , Civil Service Careers (civil-service-careers.gov.uk
Sift
Should a large number of applications be received, an initial sift may be conducted using the Personal Statement. Candidates who pass the initial sift may be progressed to a full sift,or progressed straight to assessment/interview.
Interview
If successful at application stage, you will be invited to interview where you will be assessed on Behaviours, Experience, and Strengths.
A presentation or additional exercise may also be assessed.
Sift and Interview dates
The sift will be conducted week commencing 22nd May 2023
Interviews are currently scheduled to take place by MS Teams week commencing 12th June 2023
Please note that this timeline is indicative at this stage and could be subject to change.
Salary
New entrants are expected to start on the minimum of the pay band.
Existing Civil Servants moving on level transfer will retain their current salary or move onto the pay range minimum, whichever is the higher. Staff moving on promotion will have their pay increased by 10% or move onto the pay range minimum, whichever is the higher. As a general rule allowances and supplements will not be recognised.
Blended Working Approach
We want to support your wellbeing by ensuring that flexible working is at the heart of our people offer. This means, that subject to business need, successful candidates will be offered the option to combine some working at home with working at their contractual Defra group workplace. Further information relevant to this post will be available for candidates invited to interview.
Full Time /Part Time
This is a full-time or part-time post. (Minimum of 4 days required) Job shares could be possible, although a degree of flexibility would be required so that the job holder(s) could take full responsibility for all aspects of their own work, including attendance at relevant meetings. In order for a job share to be considered there must be two people who are successful at interview who want to work in this way. Term time working would not be possible due to the short timelines assigned to the tasks and projects deadlines.
Location
Please be aware that this role(s) will be contractually based in a Defra group workplace/office (Weybridge). The successful candidate is required to carry out all their duties from a UK location and cannot do so from an overseas location at any time.
Visa Sponsorship Statement
Please take note that Defra does not hold a UK Visa & Immigration (UKVI) Skilled Worker License sponsor and are unable to sponsor any individuals for Skilled Worker Sponsorship
Reserve List
A reserve list may be held for a period of 12 months from which further appointments can be made.
Near miss
Candidates who are judged to be a near miss at interview may be considered for other positions in Defra which may be at a lower grade but have a potential skills match.
Passport
You must have a valid passport
There is a possibility of overseas travel, Therefore the successful candidate should be prepared to travel overseas if necessary.
Childcare Vouchers
Any move to Defra 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 at https://www.childcarechoices.gov.uk
Reasonable Adjustment
If a person with disabilities is put at a substantial disadvantage compared to a non-disabled person, we have a duty to make reasonable changes to our processes.
If you need a change to be made so that you can make your application, you should:
Contact Government Recruitment Service via [email protected] as soon as possible before the closing date to discuss your needs.
Complete the ‘Assistance required’ section in the ‘Additional requirements’ page of your application form to tell us what changes or help you might need further on in the recruitment process. For instance, you may need wheelchair access at interview, or if you’re deaf, a Language Service Professional.
Accessibility
If you are experiencing accessibility problems with any attachments on this advert, please contact the email address in the 'Contact point for applicants' section.
Visa Sponsorship Statement
Please take note that Defra does not hold a UK Visa & Immigration (UKVI) Skilled Worker License sponsor and are unable to sponsor any individuals for Skilled Worker Sponsorship.
Criminal Record Check
If successful and transferring from another Government Department a criminal record check may be carried out.
In order to process applications without delay, we will be sending a Criminal Record Check to Disclosure and Barring Service on your behalf.
However, we recognise in exceptional circumstances some candidates will want to send their completed forms direct. If you will be doing this, please advise Government Recruitment Service of your intention by emailing [email protected] stating the job reference number in the subject heading.
Internal Fraud Database Check
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.
Higher Security Clearance
Please be aware the levels of national security clearance are changing which may impact on the level needed for this role by the time of appointment. All efforts will be made to keep candidates informed of any changes and what that will mean in terms of vetting criteria. For more information please See our vetting charter
Feedback will only be provided if you attend an interview or assessment.
Security
See our vetting charter (opens in a new window).
Nationality requirements
This job is broadly open to the following groups:
- UK nationals
- nationals of Commonwealth countries who have the right to work in the UK
- nationals of the Republic of Ireland
- nationals from the EU, EEA or Switzerland with settled or pre-settled status or who apply for either status by the deadline of the European Union Settlement Scheme (EUSS) (opens in a new window)
- relevant EU, EEA, Swiss or Turkish nationals working in the Civil Service
- relevant EU, EEA, Swiss or Turkish nationals who have built up the right to work in the Civil Service
- certain family members of the relevant EU, EEA, Swiss or Turkish nationals
Working for the Civil Service
We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission's recruitment principles (opens in a new window).
Apply and further information
Contact point for applicants
Job contact :
Recruitment team :
Further information
If you are not satisfied with the response you receive from the Department, you can contact the Civil Service Commission:
Click here to visit Civil Service Commission
