Veterinary Pharmacovigilance Inspector

Veterinary Medicines Directorate; Addlestone; On-site; GBP 40,000 - 60,000; Full time

Job summary

The Veterinary Medicines Directorate (VMD) seeks a Pharmacovigilance Inspector to lead the UK pharmacovigilance inspection programme for Marketing Authorisation Holders, exercising expert judgement within a regulatory framework. You will oversee inspections, assess compliance risks, and provide pragmatic regulatory guidance to industry and partners.

Role requires leadership across multidisciplinary teams, strong communication, and delivery of high-impact compliance activities in a dynamic

Qualifications

• Lead and manage the UK pharmacovigilance inspection programme for MAHs.
• Apply risk-based principles to prioritise inspection activities.
• Plan, conduct, and report inspections in the UK and internationally.
• Evaluate information against Good Pharmacovigilance Practice.
• Identify non-compliance, assess risks, and provide pragmatic advice.
• Communicate inspection findings confidently while respecting views.

Responsibilities

• Support development and implementation of new pharmacovigilance legislation and guidance.
• Provide expert technical advice to industry and regulators on inspection matters.
• Contribute to enforcement and regulatory decisions under VMR 2013 and EU 2019/6.
• Maintain and enhance the Quality Management System and information security standards.

Job description

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

The Pharmacovigilance Inspector ensures that Marketing Authorisation Holders (MAHs) comply with their legal obligations for pharmacovigilance in accordance with Veterinary Medicines Regulations 2013 (as amended) (VMR) and EU 2019/6. This role is critical to safeguarding animal and public health, and the environment through rigorous inspection, compliance oversight, and stakeholder engagement. The role leads a discrete, high-impact operational area and operates within a complex scientific and regulatory framework, requiring expert judgement, leadership of inspection activities, and collaboration across multidisciplinary teams (internal VMD teams, external stakeholders and other regulators).

Your main duties will include:

Inspection and Compliance

• Lead and manage the UK veterinary medicinal product pharmacovigilance inspection programme, covering over 150 MAHs; adapting the programme as needed to support the transition to the VMR and EU 2019/6.
• Apply risk-based principles to prioritise inspection activities and compliance measures.
• Plan, conduct, and report on inspections of MAHs, and their service providers, in the UK and internationally.
• Evaluate complex information, apply relevant standards, and clarify own understanding, to assess MAH compliance with Good Pharmacovigilance Practice; identify areas of non-compliance, evaluate associated risks, and provide pragmatic advice and support to resolve issues.
• Communicate inspection findings to stakeholders confidently, defending decisions where necessary, whilst respecting differing perspectives.
• Review and assess responses to inspection findings, ensuring corrective actions are appropriate and effective. Findings may result in regulatory outcomes of varying magnitude, from issuing an improvement notice to suspending a marketing authorisation.

Regulatory and Policy Contribution

• Support the development and implementation of new legislation, policies, and guidance related to pharmacovigilance, ensuring stakeholder perspectives are considered, to deliver practical and effective outcomes.
• Provide expert technical advice to industry, government departments, and regulatory partners on inspection and compliance matters.
• Contribute to enforcement activities and regulatory decision-making to uphold compliance in accordance with VMR 2013 (as amended) and EU 2019/6.

Quality and Knowledge Management

• Maintain and enhance the VMD's Quality Management System, with a particular focus on the processes governing the pharmacovigilance inspection programme.
• Ensure effective sharing and communication of knowledge, experience, and best practices within the team and organisation, to support continuous improvement.
• Stay current with evolving scientific, regulatory, and technological developments, including advancement in digital innovation, to enhance inspection procedures and compliance oversight.

Stakeholder Engagement

• Represent the VMD, as required, at national and international meetings, seminars, and working groups, promoting the organisation's role as a leading regulator.
• Communicate, both verbally and in written form, inspection outcomes and compliance expectations clearly and professionally to external stakeholders.
• Respond to technical and procedural queries from internal and external customers.
• Build and strengthen relationships with industry representative bodies, individual pharmaceutical companies, and global regulators, fostering collaboration and information sharing to deliver mutually beneficial outcomes and enhance the VMD's reputation.

Operational Support

• Compile inspection reports and contribute to management reporting.
• Maintain accurate records and ensure timely data entry into compliance databases.
• Collaborate across VMD departments and with external regulators to coordinate inspection activities, as necessary.
• 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.