Head of Safety and Efficacy of Biologicals

Head of Safety and Efficacy of Biologicals -(Fixed location with flexible working arrangements)

£67,640 - £75,965 per annum + 25 days Annual Leave + Pension Scheme with an average employer contribution of 27%

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.

We have a vacancy for a Grade 6 Head Safety and Efficacy of Biologicals within VMD’s Authorisations Group.

This exciting and interesting job puts you at the heart of animal health and welfare in authorising biological/immunological veterinary medicinal products (VMPs) including vaccines in the UK. Your work will play a major role in assuring the quality, safety, and efficacy of these medicines and will significantly contribute to VMD’s objective of ensuring the availability of appropriate and innovative biological/immunological VMPs including vaccines to protect animal health and welfare.

You will be responsible for leading the assessment of the quality requirements of applications for marketing authorisations for biological/immunological VMPs which are authorised for use in the UK.

The role of the Head of Safety and Efficacy of Biologicals is to lead and manage the assessors involved in the assessment of safety, efficacy and overall benefit-risk of biological VMPs as well as associated work processes. You will carry out assessments of certain applications and peer review those carried out by other members of the team. You will be responsible for the continued development and training of assessors in these areas. You will lead on the formulation of national and international regulatory policies and guidelines for VMPs including novel therapy VMPs and on the provision of scientific and regulatory advice to applicants and stakeholders. You will lead on VMD’s global cooperation initiatives in regulatory affairs, work-sharing across regulatory jurisdictions, and capacity strengthening. You will report to the Head of the Biologicals Section and deputise for them.

Whilst this role within the Biologicals Section has a focus on safety and efficacy, it is expected that the job holder will be sufficiently experienced to understand the key aspects of quality, safety, and efficacy requirements of these VMPs, particularly the interdependent key attributes that contribute to/ensure the overall quality, safety, efficacy, and benefit/risk balance of the product.

The VMD is committed to supporting innovation of biological/immunological veterinary medicinal products including novel therapies VMPs. The post holder will provide expert input into the assessment of safety and efficacy aspects of medicines submitted for authorisations of novel therapies veterinary medicinal products, scientific advice, and development of guidance/regulation for these medicines.

How to Apply

If you're interested in applying for this position, we would love to hear from you! Please submit your application via the Civil Service Jobs website where you will find a full job description including salary details.

The closing date for applications is 30 September 2024.

The Veterinary Medicines Directorate is an Equal Opportunity employer.