Senior Pharamacovigilance Assessor Before you apply -Turn on alerts for jobs like this!

The Veterinary Medicines Directorate (VMD) is an Executive Agency of the Department for Environment, Food and Rural Affairs (Defra) and is responsible for ensuring the safety, quality, and efficacy of veterinary medicines in the UK., 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.


• A degree in Veterinary Science and practical clinical experience of the use of veterinary medicinal products in the different species.
• Proof of maintaining an update knowledge of Pharmacovigilance practice, regulations and current hot topics
Memberships required
• MRCVS (Member of the Royal College of Veterinary Surgeons, London. UK)
Experience required: 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 and
• 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.