Senior Pharmacovigilance Assessor
Veterinary Medicines Directorate
Apply before 11:55 pm on Monday 28th October 2024
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About the job
Job summary
This exciting and interesting job puts you at the heart of the work of the VMD’s Authorisations Division. You will be key to support the Head of Team and lead in processes related to Authorisation and Post marketing Surveillance of Veterinary Medicinal Products.
- Ensuring that a comprehensive vigilance system that can promptly detect and monitor signals across the product life cycle is in place (including during the assessment of new marketing authorisations for veterinary medicinal products, variations to existing marketing authorisations or assessment of veterinary aspects of animal test certificates to conduct clinical field trials).
- Evaluating the benefit risk of signals or other emerging safety concerns and developing effective and measurable risk mitigation measures.
- Ensuring that stakeholders are involved in the regulatory processes and appropriate messages are issued following regulatory decisions.
- Pro-active risk management of the transition to the new VMR, focusing on the change from PSUR to Benefit Risk Report (BRR) to minimise any potential associated risks.
- Collaboration with members of the Authorisations Division to achieve the Division’s overall objectives.
The Pharmacovigilance team provides effective regulation of the post marketing use of veterinary medicinal product, underpinned by science and research, contributing to the VMD’s strategic objective to protect public health, animal health and the environment and promote animal welfare by ensuring the quality, safety and efficacy of veterinary medicines. In collaboration with the Head of Team, you will provide strategic leadership mentoring and supervising more junior scientific officers; operational delivery; develop international regulatory collaboration; ensure the quality of the team’s outputs; engage with colleagues, delivery partners, stakeholders and users of our services.
Job description
The post-holder’s main duties will be to:
- Use your veterinary clinical experience and Pharmacovigilance knowledge and expertise to undertake the collection and detailed scientific assessment and evaluation of high-quality safety data, produce reports such as the Monthly Signal Report, and collaborating with the team decide and communicate the most appropriate course of action.
- Maintain and develop a thorough working knowledge of your own specialism and awareness of current developments, legislation and guidance affecting veterinary medicinal products and matters.
- Managing other veterinary assessors in the team and work allocation. Provide guidance to and develop junior assessors through relevant training and mentoring,
- Ensure the team successfully reacts to global regulatory changes and implements them timely. (i.e. Annual updating: WHO ATCvet Code, VeDDRA and VICH GL30 and produce or update VMD guidance to industry).
- Ensure VMD contributes to wider Government initiatives concerning monitoring of safety, efficacy and quality of veterinary medicinal products.
- Identify emerging risks and issues and manage accordingly (risk identification and minimisation, appropriate escalation).
- Lead the production of relevant training materials and knowledge management and communication for different audiences including external stakeholders (i.e. delivery of the e-Pharmacovigilance Training in collaboration with VMD International Team and Training Centre).
- Contribute to the planning and implementation of the Pharmacovigilance electronic system and databases.
- Deputising for the Head of Team when needed to report to internal decision-making groups (i.e. Alert Meeting, LBFG, VPC). Plan and deliver presentations to external stakeholders (i.e. NOAH and QUINS Pharmacovigilance subgroups) and participate in relevant international and national committees, meetings and working groups.
- Support the Head of Team in taking forward opportunities for global collaboration and work-sharing across regulatory jurisdictions regarding Pharmacovigilance and promoting VMD as a leading regulator.
- Based on your extensive regulatory and technical expertise, provide technical and scientific leadership on Pharmacovigilance for veterinary medicines and veterinary matters (including ensuring the continued availability of veterinary medicines) to both internal and external stakeholders. Be a point of contact for external queries on matters relating to Signal Detection and Benefit Risk Assessment.
- Establish enhanced external regulatory and scientific networks including with other medicines regulators, and external stakeholders to build effective alliances to deliver mutually beneficial outcomes and develop the team expertise.
- Determine priorities and organising resources to ensure the quality of the service provided by the team to others within VMD and to stakeholders including compliance with appropriate legislation, business priorities, hot topics and published standards.
- Implement the changes to Pharmacovigilance activities arising from revised legislation in GB and NI and subsequent quality management realising process / business improvements and efficiencies. Internal QMS– production of documentation and review of systems/ processes/documentation.
- Communications/ Engagement: including response to FOIs or ministerial correspondence/ response to Urgent Safety Signals and EMA Non-Urgent Information requests.
- Publications: social media/ Gov.UK Safety Updates/ Articles - Provide clinical/technical/scientific input into the content of timely and effective safety communications to other regulators, healthcare professionals, companies, and other stakeholders.
- Horizon scanning for new/emerging technologies, active substances and diseases; identifying associated regulatory and/or scientific gaps and new ethical considerations to facilitate innovation and minimise risk through risk management plans/ Post Authorisation Studies.
- Actively supporting the VMD R&D programme by sponsoring research programmes and/or providing scientific critique.
- Comply with ISO 9001 (quality management) and ISO 27001 (information security) standards, and GDPR and record management requirements.
- Act corporately – meeting, role-modelling, embedding, and championing the corporate objectives set by the VMD.
Person specification
Candidates must have the experience and qualifications set out below:
You must have a good understanding and relevant experience in the regulation of medicinal products, an understanding of the legislative process and of the wider regulatory environment and be a good communicator. You will need to demonstrate experience in:
- clinical, regulatory, and/or pharmaceutical sector (at least 4 years).
- analysing and accurately interpreting data from various sources to support decisions.
- presenting reasonable conclusions from a wide range of complex and sometimes incomplete evidence.
- in depth knowledge and/or experience of relevant regulations and procedures applicable to veterinary medicinal products to improve the team capability for benefit risk evaluation and safety and surveillance function.
- experience of critically analysing complex clinical/scientific/technical information from a number of sources under pressure and make appropriate recommendations or decisions to protect animal and public health and the environment even when the evidence is not clear.
- promoting and drive continuous improvement on pharmacovigilance and risk-management topics and communication.
- lead on the development of accurate and informative Ministerial submissions, Enquiries, Freedom of Information requests and press enquiries, relating to benefit/risk evaluations, sometimes to tight deadlines.
- providing advice of complex issues in a way that is easy to understand.
- management of key business processes subject to demanding deadlines and managing conflicting priorities.
- developing business relationships.
- providing strategic leadership.
You must also have experience in or awareness of, or a demonstrable ability to get up to speed rapidly:
- extensive knowledge of GB VMR, post marketing monitoring systems for authorised veterinary medicines.
- an understanding of EU 2019/6 as it applies in NI.
- an understanding of the processes bringing about legislative change.
IT Skills
You must be proficient in the use of Microsoft Office packages, particularly Word, Excel and Outlook. You must use the internet effectively and have the aptitude to learn how to use the VMD’s bespoke IT systems and work following Agile methodology.
Qualifications
• Proof of maintaining an up to date knowledge of Pharmacovigilance practice, regulations and current hot topics.
Memberships
Behaviours
We'll assess you against these behaviours during the selection process:
- Making Effective Decisions
- Communicating and Influencing
- Changing and Improving
- Seeing the Big Picture
We only ask for evidence of these behaviours on your application form:
- Making Effective Decisions
- Communicating and Influencing
- Changing and Improving
Technical skills
We'll assess you against these technical skills during the selection process:
- Knowledge of veterinary medicinal products regulations and Benefit Risk evaluation, and experience of critically analysing complex clinical/ scientific/ technical information from a number of sources and make appropriate decisions.
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 employer contribution of 28.97%
- 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.
Further details around what this will entail are listed on the application form.
The CV will ask for your job history, qualifications and past skills and experience.
Your Personal Statement should be no more than 500 words and should demonstrate how your qualifications / knowledge / skills / experience match the requirements set out in the job advert.
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 Technical Skill.
A presentation or additional exercise may also be assessed.
Sift and Interview dates
The sift will be conducted week commencing 4th November 2024.
Interviews are currently scheduled to take place by MS Teams week commencing 18th November 2024.
Please note that this timeline is indicative at this stage and could be subject to change.
Reserve List
A reserve list may be held for a period of 12 months from which further appointments can be made.
Location
As part of the pre-employment process for this post, successful candidate(s) will be able to agree a contractual workplace from those locations listed in this advert. The agreed contractual workplace is then the substantive and permanent place of work for the successful candidate(s)
Where the location is ‘National’ the successful appointee should discuss and agree an appropriate contractual location in line with both Defra’s location policy and site capacity, prior to proceeding with pre-employment processes.
Successful applicants currently employed by the hiring Defra organisation for this post may choose to remain in their current contractual location or may choose to change contractual location to one of those listed above. This should be discussed and agreed prior to proceeding with pre-employment processes.
The agreed amount of time spent at a workplace for this post will reflect the requirement for Civil Servants to spend at least 60% of their working time in an organisation workplace with the option to work the remaining time flexibly from home. Working time spent at a workplace may include time spent at other organisational locations including field-based operational locations, together with supplier, customer or partner locations. This is a non-contractual agreement which is consistent with common Civil Service expectations.
Travel costs to non-contractual workplaces will be subject to departmental travel and subsistence policies. Travel costs to contractual workplaces are the responsibility of the employee.
Defra includes the core department, APHA, RPA, Cefas and VMD.
Please be aware that this role(s) will be contractually based at the VMD headquarters in Addlestone, Surrey. Fixed location, but flexible working arrangements.
Working Pattern
This is a full-time post. It may be possible for individuals to fill these roles on an 80% FTE basis, but no less due to the tight time constraints of the work commitments.
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 in order to assist to international meetings and other activities representing VMD.
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.
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.
Salary
New entrants are expected to start on the minimum of the pay band.
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 Pre-EmploymentChecks.grs@cabinetoffice.gov.uk stating the job reference number in the subject heading.
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.
Please note tests on this vacancy are timed, therefore if due to the need for a reasonable adjustment such as additional time contact us as below.
If you need a change to be made so that you can make your application, you should:
- Contact Government Recruitment Service via defrarecruitment.grs@cabinetoffice.gov.uk 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.
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.
NSV
For further information on National Security Vetting please visit the following page https://www.gov.uk/government/publications/demystifying-vetting
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.
All of these posts require the successful candidate to hold basic security clearance. Candidates may be subject to a higher level of clearance because of the security requirements for this location. Job offers to these posts are made on the basis of merit. Security vetting will only take place after the receipt of a job offer.
Childcare Vouchers
Any move to Defra from another employer will mean you can no longer access childcare vouchers. You may however be eligible for other government schemes, including Tax Free Childcare. Determine your eligibility at https://www.childcarechoices.gov.uk
Feedback will only be provided if you attend an interview or assessment.
Security
Nationality requirements
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).
Diversity and Inclusion
Apply and further information
Contact point for applicants
Job contact :
- Name : Blanca Berrocal-Gonzalez
- Email : b.gonzalez@vmd.gov.uk
Recruitment team
- Email : DefraRecruitment.grs@cabinetoffice.gov.uk
Further information
Government Recruitment Services via email: defrarecruitment.grs@cabinetoffice.gov.uk
If you are not satisfied with the response you receive from the Department, you can contact the Civil Service Commission: Click https://civilservicecommission.independent.gov.uk/contact-us/ to visit Civil Service Commission.
