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Head of Pharmacovigilance

Posting date:	28 October 2024
Salary:	£70,690 to £79,160 per year
Hours:	Full time
Closing date:	25 November 2024
Location:	KT15 3LS
Company:	Government Recruitment Service
Job type:	Permanent
Job reference:	373722/1

Summary

This exciting and interesting post puts you at the heart of the Veterinary Medicines Directorate’s (VMD) role in being the regulatory and policy lead responsible for issues concerning the authorisation, use, and manufacture of veterinary medicines in the UK.

The VMD’s 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.

As Head of Pharmacovigilance, you will be responsible for the post-authorisation surveillance of veterinary medicines through the collation of suspected adverse event reports among other mechanisms.

Veterinary medicines regulation has undergone a period of significant change due to the introduction of new legislation in Great Britain (GB), and the continued adjustment to the new landscape following Brexit with veterinary medicines regulation operating slightly differently in Northern Ireland (NI). This adds to the complexity of the work dealt with by the VMD.

Your main duties will include:

• To shape policy and provide authoritative advice to senior grades and Ministers, with the discretion to set the strategic direction for the management and implementation of Pharmacovigilance (PhV) across the UK.
• As a key leader, you will support the Director of Authorisations in helping to maintain a well-trained and motivated workforce, and in helping to deliver on the wider business objectives of the VMD; ensuring that safe and efficacious veterinary medicines are available in Great Britain and Northern Ireland.
• Taking ownership and accountability for matters related the post marketing surveillance of Veterinary Medicinal Products representing these views across the VMD, ensuring that coordinated action and wider issues are considered.
• Leading and managing a team of staff, including a PhV Inspector, ensuring a comprehensive system is in place that can promptly detect and monitor signals across the product life cycle. The Team will lead on all aspects of PhV; evaluate signals being detected; consider whether further risk mitigation is necessary to maintain the positive benefit:risk conclusion of authorised products; and to develop effective risk mitigation measures. You will ensure compliance to business standards and delivery against published key performance indicators. (KPIs).
• In a complex sector, you will manage the transition to the revised Veterinary Medicines Regulations (VMR) and advise on breaches of these Regulations.
• Representing the VMD at national and international events, at external stakeholder meetings, and other industry related fora and conferences. Engaging, developing and enhancing relationships with various networks, veterinary representative groups, industry representative bodies, individual pharmaceutical companies, the European Medicines Agency (EMA) and with other EU and Global regulators as we take forward opportunities for global collaboration and work-sharing across regulatory jurisdictions, promoting VMD as a leading regulator and building effective alliances to deliver mutually beneficial outcomes.
• In a high-profile and complex area with associated reputational risks, you will deliver complex messages targeted to a range of audiences ranging from experts to lay-persons. You will analyse information, report on outcomes identifying key issues and risks and make recommendations to VMD senior managers, liaise internally across the various expert disciplines to agree a way forward and implement the resulting plans.
• As an effective change manager, you will lead on the implementation of enhanced PhV electronic IT systems and databases, revise reporting methods and improve our ways of working to maximise operational effectiveness ensuring high-quality operational delivery within available resources.
• Coordinating the collection of high-quality safety data, analysis, and production of the Signal Monthly Report, including chairing the Alert Meeting and presenting key messages to the independent advisory Veterinary Products Committee.
• As appropriate respond to Freedom of Information requests; Ministers Correspondence; respond to Urgent Safety Signals and to EMA Non-Urgent Information requests; and as necessary respond to social media activity and provide articles and advice to healthcare professionals, and to professional journals.
• Ensuring the team reacts appropriately to global regulatory changes and implements them in a timely manner, providing advice and messaging accordingly.
• Complying with ISO 9001 (quality management) and ISO 27001 (information security) standards, and GDPR and record management requirements.
• Acting corporately – meeting, role-modelling, embedding and championing the corporate objectives set by the VMD.