Head of Pharmacovigilance

This role will be contractually based at the VMD, Woodham Lane, New Haw, Addlestone, Surrey KT15 3LS. This is a fixed location; the VMD does not use hubs located elsewhere in the UK.
You will be expected to spend at least 60% of your working time in an organisation workplace with the option to work the remaining time flexibly from home. Organisation workplace includes the VMD office as well as time spent at other locations for meetings, conferences, and field-based activities. This is a non-contractual agreement which is consistent with common Civil Service expectations.
This role is not suited to a homeworking contract.
Travel costs to non-contractual workplaces will be subject to departmental travel and subsistence policies. Travel costs to contractual workplaces are the responsibility of the employee.
The successful candidate will be required to carry out all their duties from a UK location and cannot do so from an overseas location unless they have permission to do so., 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., We'll assess you against these behaviours during the selection process:
o Delivering at Pace
o Changing and Improving
o Leadership
o Communicating and Influencing, Your Personal Statement should be no more than 750 words and should demonstrate how your qualifications / knowledge / skills / experience match the requirements set out in the job advert.
When giving examples of Behaviours please use the Situation, Task, Action, Result (STAR) format. Behaviours , Civil Service Careers (civil-service-careers.gov.uk)
Sift
Should a large number of applications be received, an initial sift may be conducted using the lead behaviour Delivering at Pace
Candidates who pass the initial sift may be progressed to a full sift, or progressed straight to assessment/interview.
Interview
If successful at application stage, you will be invited to interview where you will be assessed on Behaviours, Experience, and Strengths.
A presentation or additional exercise may also be assessed.
Sift and Interview dates
The sift will be conducted week commencing 25th November 2024.
Interviews are currently scheduled to take place in person at the VMD during the weeks commencing 9th December 2024.
Please note that this timeline is indicative at this stage and could be subject to change.
Reserve List
A reserve list may be held for a period of 12 months from which further appointments can be made.
Working Pattern
This is a full-time post. It may be possible for individuals to fill these roles on an 80% FTE basis, but no less due to the tight time constraints of the work commitments.
Job shares could be possible, although a degree of flexibility would be required so that the job holder(s) could take full responsibility for all aspects of their own work, including attendance at relevant meetings. In order for a job share to be considered there must be two people who are successful at interview who want to work in this way.
Passport
You must have a valid passport
There is a possibility of overseas travel. Therefore the successful candidate should be prepared to travel overseas if necessary in order to assist to international meetings and other activities representing VMD.
Near miss
Candidates who are judged to be a near miss at interview may be considered for other positions in Defra which may be at a lower grade but have a potential skills match., Please be aware the levels of national security clearance are changing which may impact on the level needed for this role by the time of appointment. All efforts will be made to keep candidates informed of any changes and what that will mean in terms of vetting criteria. For more information please See our vetting charter.
Childcare Vouchers
Any move to Defra from another employer will mean you can no longer access childcare vouchers. You may however be eligible for other government schemes, including Tax Free Childcare. Determine your eligibility at https://www.childcarechoices.gov.uk
Feedback will only be provided if you attend an interview or assessment.

Security
Successful candidates must undergo a criminal record check.
Successful candidates must meet the security requirements before they can be appointed. The level of security needed is counter-terrorist check (opens in a new window).See our vetting charter (opens in a new window).
People working with government assets must complete baseline personnel security standard (opens in new window) checks.

Nationality requirements
This job is broadly open to the following groups:
o UK nationals
o nationals of the Republic of Ireland
o nationals of Commonwealth countries who have the right to work in the UK
o nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities with settled or pre-settled status under the European Union Settlement Scheme (EUSS) (opens in a new window)
o nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities who have made a valid application for settled or pre-settled status under the European Union Settlement Scheme (EUSS)
o individuals with limited leave to remain or indefinite leave to remain who were eligible to apply for EUSS on or before 31 December 2020
o Turkish nationals, and certain family members of Turkish nationals, who have accrued the right to work in the Civil Service
Further information on nationality requirements (opens in a new window)

Working for the Civil Service
The Civil Service Code (opens in a new window) sets out the standards of behaviour expected of civil servants.
We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission's recruitment principles (opens in a new window).
The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria.
The Civil Service also offers a Redeployment Interview Scheme to civil servants who are at risk of redundancy, and who meet the minimum requirements for the advertised vacancy.

Diversity and Inclusion
The Civil Service is committed to attract, retain and invest in talent wherever it is found. To learn more please see the Civil Service People Plan (opens in a new window) and the Civil Service Diversity and Inclusion Strategy (opens in a new window).

Apply and further information
This vacancy is part of the Great Place to Work for Veterans (opens in a new window) initiative.
The Civil Service welcomes applications from people who have recently left prison or have an unspent conviction. Read more about prison leaver recruitment (opens in new window).
Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records.

You must have a good understanding and relevant experience in, or a demonstrable ability to get up to speed rapidly, in the regulation of medicinal products, the legislative process, and Pharmacovigilance and the wider regulatory environment.
We’re looking for you to have experience of / in:
+ developing and leading a team
+ developing business relationships
+ providing strategic leadership
+ leading change
+ management of key business processes subject to demanding deadlines and managing conflicting priorities
+ providing advice on complex issues in a way that is easy to understand
We’re looking for someone that:
+ Is a good communicator, both orally and in writing.
+ Is proactive, working on your own initiative using a variety of media to communicate messages and reporting progress against strategic objectives or targeted outcomes.
+ Is proficient in the use of Microsoft Office 365 packages, particularly Microsoft Teams, Word, Excel, PowerPoint, and Outlook, and can learn in-house packages quickly., Degree in veterinary science

Alongside your salary of £70,690, Veterinary Medicines Directorate contributes £20,478 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides.
o Learning and development tailored to your role
o An environment with flexible working options
o A culture encouraging inclusion and diversity
o A Civil Service pension with an employer contribution of 28.97%
o Free onsite parking
o Free eyesight test
o Onsite gym
o Access to a prayer room, New entrants are expected to start on the minimum of the pay band.
Visa Sponsorship Statement
Please take note that Defra does not hold a UK Visa & Immigration (UKVI) Skilled Worker License sponsor and are unable to sponsor any individuals for Skilled Worker Sponsorship.
Criminal Record Check
If successful and transferring from another Government Department, a criminal record check may be carried out.