Veterinary Pharmacovigilance Assessor (Inspections)

Job summary

About the VMD

The VMD is the regulatory and policy lead responsible for issues concerning the authorisation, use, and manufacture of veterinary medicines in the UK.

Our aim is to protect public health, animal health, and the environment, and promote animal welfare by assuring the safety, quality and effectiveness of veterinary medicines.

Find out more at: About us - Veterinary Medicines Directorate - GOV.UK

About the Job

This exciting and interesting role puts you at the heart of UK veterinary medicine post-authorisation pharmacovigilance activities. The Pharmacovigilance team safeguards health through the detection and assessment of safety signals, regular benefit-risk reviews of veterinary medicinal products (VMPs), inspection of Marketing Authorisation Holders (MAHs), evidence-based regulatory decision making and effective communication with stakeholders.

You will be a pharmacovigilance assessor within the Authorisations Division contributing to each of these areas but with a focus on supporting inspections of MAHs. Your work will ensure that VMPs remain safe and effective for use in the UK and will significantly contribute to the VMD meeting its published standards.

Job description

Your main duties will be to:

• Support the lead inspector during routine and targeted inspections of MAH pharmacovigilance systems and provide veterinary pharmacovigilance assessment expertise in key areas.
• Assess adverse event reports, periodic reports, variations and rapid alerts for authorised veterinary medicines and assist in assessment applications for new marketing authorisations.
• Perform signal detection, evaluation and benefit-risk assessment for veterinary medicines and propose appropriate regulatory action where needed.
• Peer-review assessments and other communications prepared by other assessors or compliance officers within the team.
• Provide regulatory and scientific technical advice to internal and external stakeholders.
• Respond to internal and external enquiries and contribute to Gov.uk publications.
• Contribute to the development and maintenance of the team's quality management system.
• Maintain awareness of current developments, legislation and guidance affecting veterinary medicines within National and International context.
• Collaborate with other teams within the Authorisations Division to achieve the Division's overall objectives.
• Contribute to wider VMD initiatives, such as training and education, publicity programmes, R&D programme.
• Act corporately - meeting, role-modelling, embedding, and championing the corporate objectives set by the VMD.
• Comply with ISO 9001 (quality management) and ISO 27001 (information security) standards, and GDPR and Information Management requirements.

You may also be asked to:

• Manage and develop other assessors in the team and build capability through provision of relevant training and mentoring.
• Represent the work of the pharmacovigilance team and the VMD in national and international committees.
• Participate in external stakeholder and international regulatory collaborative meetings.
• Collaborate in the continuous improvement and review of the pharmacovigilance IT system.

Person specification

You must have the skills, experience, formal qualification and membership set out below.

Skills and Experience

You will have extensive experience of the use and regulation of veterinary medicines in the UK gained from at least one of the following:

• experience of clinical veterinary work;
• experience in pharmacovigilance or regulatory affairs from the pharmaceutical industry;
• experience as an assessor in another veterinary national competent authority;
• experience in academia.

You must also have/ be:

• experience in scientific writing and data analysis.
• experience, or an awareness, of clinical veterinary work.
• a good understanding of current animal health and topical veterinary issues.
• proficient in the use of Microsoft Office packages, particularly Word, Excel and Outlook.
• an effective user of the internet and have the aptitude to learn the use of the VMD’s bespoke IT systems.

Qualifications

A degree in Veterinary Medicine.

Memberships

MRCVS (Member of the Royal College of Veterinary Surgeons, London. UK), or eligible to become MRCVS prior to taking employment.

Behaviours

We'll assess you against these behaviours during the selection process:

• Making Effective Decisions
• Delivering at Pace
• Communicating and Influencing

Benefits

Alongside your salary of £47,557, Veterinary Medicines Directorate contributes £13,777 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides (opens in a new window).

• Learning and development tailored to your role
• An environment with flexible working options
• A culture encouraging inclusion and diversity
• A Civil Service pension is one of the best workplace pension schemes in the UK public sector, with an average employer contribution of 28.97%
• Free onsite parking
• Free eyesight test
• Onsite gym
• Access to a prayer room

Awork-life balance is key for us all. We offer flexible working as well as health, well-being and discount schemes. The annual leave package starts at 25 days per year and increases to 30 days over five years. We offer generous maternity, paternity, shared, and adoption leave.

This gives you a flavour of what’s available, but there is so much more we could mention – see Civil Service Employee Benefits , Civil Service Careers for further information.

Things you need to know

Artificial intelligence

Artificial intelligence can be a useful tool to support your application, however, all examples and statements provided must be truthful, factually accurate and taken directly from your own experience. Where plagiarism has been identified (presenting the ideas and experiences of others, or generated by artificial intelligence, as your own) applications may be withdrawn and internal candidates may be subject to disciplinary action. Please see our candidate guidance (opens in a new window) for more information on appropriate and inappropriate use.

Selection process details

This vacancy is using Success Profiles (opens in a new window), and will assess your Behaviours, Strengths and Experience.

Further information about success profiles with guidance on how to complete your application form is available here - About the application process , Civil Service Careers

Application Process

As part of the application process, you will be assessed on your