Scientific Officer

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 These exciting and interesting roles put you at the heart of the important work of the VMD's Biologicals Section and the authorisation in the UK of biological/immunological veterinary products, including vaccines and novel therapy veterinary medicinal products. Your primary role will be to assess the quality, safety and efficacy data submitted by pharmaceutical companies in support of their applications of marketing authorisations for biological/immunological veterinary medicinal products. These applications will include complex variations to existing marketing authorisations and sections of applications for new marketing authorisations. You will also support other scientists and veterinarians in the assessment of more complex applications. You will work within a peer-reviewed environment and contribute to ensure that the applications are determined in accordance with the defined targets, contributing to the VMD meeting its published standards. Your work will also play a major role in helping to ensure the continuing quality, safety and efficacy of veterinary medicines. The VMD is a leading regulator of veterinary medicines and has an active international profile. Your work will support the VMD's aim to protect public health, animal health, and the environment and promote animal welfare by assuring the safety, quality and efficacy of veterinary medicines. You will be responsible for:

• assessment of quality, safety and efficacy data of applications for variations to existing marketing authorisations for biological/immunological veterinary medicines, including novel therapy veterinary medicinal products.
• assessment of sections of quality, safety and efficacy data of applications for new marketing authorisations for biological/immunological veterinary medicines in collaboration with the lead assessor.
• contributing to other application activities of the Biologicals Section including batch release of immunological veterinary medicinal products.
• control of Biologicals Section Quality Management System (QMS).
Your main duties will be :
• scientifically assess quality, safety and efficacy data submitted by marketing authorisation holders in support of applications for variations (primarily complex Type II variations) to current marketing authorisations in line with legislative timelines and relevant guidance documents.
• scientifically assess sections of quality, safety and efficacy data of applications for new marketing authorisations in line with legislative timelines and relevant guidance documents, in collaboration with the lead assessor.
• undertake a detailed evaluation of the data and in liaison with senior assessors in the Biologicals Team to formulate recommendations to accept or refuse the applications based on the benefits and risks you identify during the assessment. prepare written assessment reports.
• communicate your assessments clearly to internal decision-making groups - to enable them to decide whether the data satisfy regulatory requirements and to decide on a course of action.
• advise applicants on technical and regulatory aspects of potential and ongoing applications.
• deal with enquiries and represent the Biologicals Section at meetings with internal and external stakeholders.
• undertake lead role in batch release activities for immunological veterinary medicinal products, supporting peers and junior assessors.
• contribute to capability within the Biologicals Section through provision of relevant training to peers and in the development of junior assessors.
• peer review of assessment reports prepared by junior assessors.
• control documents of the Biologicals Team Quality Management Systems (QMS), act as QMS representative for the Team and participate in internal and external audits and ensure team reference documents are up to date.
• maintain awareness of current developments and legislation affecting biological/immunological veterinary medicinal products.
• participate in 3Rs (Replacement, Reduction and Refinement) initiatives at National and International level.
• comply with ISO 9001 (quality management) and ISO 27001 (information security) standards, and GDPR and Information management requirements.
• act corporately - meeting, role-modelling, embedding, and championing the corporate objectives set by the VMD.
Though these are not part of your main duties, we may also ask you to:
• line manage, supervise and develop Higher Scientific Officers within the Biologicals Section.
• contribute to development and revision of scientific and regulatory guidelines.
• contribute to the delivery of the VMD International Strategy (which may involve foreign travel).
• contribute to the VMD Regulatory Science Strategy.
• contribute to work to ensure the continued availability of veterinary vaccines.
• contribute to assessment of applications for manufacturing authorisations for inactivated autogenous vaccines
• contribute to assessment of applications for Animal Test Certificates to conduct clinical field trials.