Veterinary Pharmacovigilance Assessor - New Haw, United Kingdom - Veterinary Medicines Directorate
Description
Details:
Reference number:
Salary:
- £42,577 - £47,039
- A Civil Service Pension with an average employer contribution of 27%
Job grade: - Senior Executive Officer
- SSO
- Senior Scientific Officer
Contract type: - Permanent
Business area: - VMD Pharmacovigilance Team
Type of role: - Science
Working pattern: - Flexible working, Fulltime, Job share, Parttime
Number of jobs available: - 1Contents
About the job
Benefits:
Things you need to know
Location
- VMD, Woodham Lane, New Haw, Addlestone, Surrey KT15 3LS (Fixed location, but flexible working arrangements)About the job
Job summary:
- As a veterinary assessor within the Pharmacovigilance Team, you will contribute to the VMD's aims and objectives by monitoring reports of suspected adverse events and lack of efficacy following use of veterinary medicinal products, in order to ensure that the benefit/risk balance of these products remains positive
Job description:
Your main duties will be to:
- monitor and assess adverse events reports following use of veterinary medicinal products in order to detect trends which reflect on the safety, quality and efficacy of products authorised for use in the UK
- perform signal detection analyses within the pharmacovigilance databases and undertake a detailed evaluation of the data and, in liaison with other assessors, interpret the clinical significance of the results obtained
- assess the benefit/risk balance of veterinary medicinal products based on surveillance data
- formulate recommendations and plan suitable risk mitigation measures based on Signal Management outcome
- participate in the assessment of the variations to the marketing authorisations of veterinary medicinal products following pharmacovigilance activities
- maintain awareness of current developments, legislation and guidance affecting veterinary medicinal products within national and international contexts
- provide relevant expert advice to assessors from other scientific disciplines within the VMD, other government departments and external stakeholders
- deal with pharmacovigilance related queries from stakeholders (enquiries and Access to Information requests); including data extraction from the pharmacovigilance databases in order to provide the requested information
- participate in pharmacovigilance inspections when required
- respond to rapid alerts from a pharmacovigilance perspective, identifying areas of concern or request for further information
- contribute to the scientific publications from the VMD in the context of pharmacovigilance
- manage and develop other assessors in the team and build capability through provision of relevant training and mentoring
- collaborate with members of the Authorisations Division to achieve the Division's overall objectives
- comply with ISO 9001 (quality management) and ISO information security) standards, and GDPR and record management requirements
- act corporately - meeting, role-modelling and embedding the corporate objectives set by the VMD and challenging others if they are not.
Though these won't be part of your main duties, we may also ask you to:
- contribute to the development and revision of industry guidelines
- contribute to the VMD's Regulatory Science Strategy
- represent the work of the Pharmacovigilance team and the VMD in national and international committees
- contribute to wider VMD initiatives, such as training and education, publicity programmes.
Person specification:
You must have both the formal qualification and the experience set out below.
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 the pharmaceutical industry; experience as an assessor in another veterinary national competent authority; experience in academia.
You must have a good understanding of current animal health and topical veterinary issues.
You must have experience in scientific writing and data analysis.
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.
Qualifications:
- You must hold a degree in veterinary medicine
Memberships:
- You must be a member of the Royal College of Veterinary Surgeons
Behaviours:
We'll assess you
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