Senior Veterinary Pharmacovigilance Assessor in Bradford

About the VMD

You may not have heard of the Veterinary Medicines Directorate (VMD), but have you ever:

• eaten meat, eggs, fish or honey
• drunk milk
• owned a pet or animal
• taken antibiotics

If you said yes to any of the above, you are directly affected by what the VMD does. 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.

About the Job

This exciting and high-impact job puts you at the heart of post-authorisation surveillance of veterinary medicines for the UK market and plays a major role in assuring the ongoing assessment of the benefit-risk balance for the use of these medicines. As a senior member of the Pharmacovigilance (PhV) team within the Authorisations Division, you will help protect animal, environmental and public health through a globally recognised approach to pharmacovigilance.

The PhV Team's vision is to safeguard 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
• effective communication with stakeholders

Following recent amendments to the Veterinary Medicines Regulations 2013 (as amended) (VMR), pharmacovigilance obligations have significantly expanded, increasing data volumes and strengthening inspection, oversight and analytical requirements. The PhV Team is therefore restructuring to meet these enhanced regulatory and operational demands.

We are seeking a senior veterinary professional with strong experience in scientific assessment, regulatory enforcement, and scientific communication. You will contribute expert scientific risk-based evaluation and leadership to ensure that veterinary medicines remain safe and effective for use in the UK.

In this role, you will:

• contribute to applications assessments, including variations to Marketing Authorisations (MAs), by evaluating data and implementing regulatory actions, including risk mitigations to help ensure the quality, safety, efficacy, and availability of VMPs in the UK.
• line manage and support assessors, inspectors and support staff, helping to lead a fast-paced, demand-led area of surveillance.
• oversee the production of internal and external reports and management information, supporting evidence-based decision-making and regulatory compliance.
• stay informed on developments in pharmacovigilance and veterinary medicines regulation and proactively contribute to the development and review of scientific and regulatory guidelines that support product quality, safety, efficacy, and industry innovation.
• operate within a complex scientific and legislative environment, applying veterinary and scientific expertise while embracing innovation and supporting the UK's international reputation as a leading regulator of veterinary medicines.

Your main responsibilities and duties will be to:

• Evaluate post authorisation safety and efficacy data and assess the post authorisation benefit–risk balance of pharmaceuticals and biological/immunological VMPs, including vaccines and novel therapies, applying expert scientific judgement and clinical experience to interpret complex evidence and contribute to signal detection and support regulatory decision making.
• Assure the quality of some of the assessments of more junior assessors in the team, peer reviewing work prepared by other Pharmacovigilance assessors.
• Lead and manage an area within Pharmacovigilance, ensuring effective planning, prioritisation and quality assured delivery of workstreams aligned with regulatory deadlines and organisational priorities, including holding responsibilities for relevant parts of the team Quality Management System (QMS) and documentation.
• Coordinate and develop pharmacovigilance reporting and KPI monitoring, providing robust management information for internal governance and external publication, offering assurance on surveillance activities.
• Assess and manage PhV input into applications related to Marketing Authorisations to contribute to the benefit-risk assessment of the product and advise applicants on technical aspects of potential and ongoing applications.
• Efficient written and oral communications with MAH representatives, industry representative bodies and other stakeholders.
• Manage and develop other assessors in the team and build capability through provision of relevant training and mentoring.
• Conduct horizon scanning and contribute to PhV research and development, identifying emerging technologies, substances and diseases, progressing research proposals and approved projects, and contributing to the VMD's innovation agenda.
• Represent the VMD in national and international working groups, contributing veterinary and pharmacovigilance expertise to collaborative regulatory initiatives.
• Maintain deep and up to date knowledge of relevant national and international legislation, guidelines and scientific developments, contributing to the VMD's regulatory science strategy and work on VMP availability.
• Act corporately, complying with ISO 9001 (quality management), ISO 27001 (information security), GDPR and records management requirements, and upholding Civil Service values.

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.