Job summary
This exciting and interesting job puts you at the heart of the work of the VMD�s Authorisations Division. You will be key to support the Head of Team and lead in processes related to Authorisation and Post marketing Surveillance of Veterinary Medicinal Products. �
1. Ensuring that a comprehensive vigilance system that can promptly detect and monitor signals across the product life cycle is in place (including during the assessment of new marketing authorisations for veterinary medicinal products, variations to existing marketing authorisations or assessment of veterinary aspects of animal test certificates to conduct clinical field trials).
2. Evaluating the benefit risk of signals or other emerging safety concerns and developing effective and measurable risk mitigation measures.
3. Ensuring that stakeholders are involved in the regulatory processes and appropriate messages are issued following regulatory decisions.
4. Pro-active risk management of the transition to the new VMR, focusing on the change from PSUR to Benefit Risk Report (BRR) to minimise any potential associated risks.
5. Collaboration with members of the Authorisations Division to achieve the Division�s overall objectives.� � � � � � � � � � � � � � � � � � � � � � � � � � � � � �
The Pharmacovigilance team provides effective regulation of the post marketing use of veterinary medicinal product, underpinned by science and research, contributing to the VMD�s strategic objective to protect public health, animal health and the environment and promote animal welfare by ensuring the quality, safety and efficacy of veterinary medicines. �In collaboration with the Head of Team, you will provide strategic leadership mentoring and supervising more junior scientific officers; operational delivery; develop international regulatory collaboration; ensure the quality of the team�s outputs; engage with colleagues, delivery partners, stakeholders and users of our services.
Job description
The post-holder�s main duties will be to:
6. Use your veterinary clinical experience and Pharmacovigilance knowledge and expertise to undertake the collection and detailed scientific assessment and evaluation of high-quality safety data, produce reports such as the Monthly Signal Report, and collaborating with the team decide and communicate the most appropriate course of action.
7. Maintain and develop a thorough working knowledge of your own specialism and awareness of current developments, legislation and guidance affecting veterinary medicinal products and matters.
8. Managing other veterinary assessors in the team and work allocation. Provide guidance to and develop junior assessors through relevant training and mentoring,
9. Ensure the team successfully reacts to global regulatory changes and implements them timely. ( Annual updating: WHO ATCvet Code, VeDDRA and VICH GL30 and produce or update VMD guidance to industry).
10. Ensure VMD contributes to wider Government initiatives concerning monitoring of safety, efficacy and quality of veterinary medicinal products. �
11. Identify emerging risks and issues and manage accordingly (risk identification and minimisation, appropriate escalation).
12. Lead the production of relevant training materials and knowledge management and communication for different audiences including external stakeholders ( delivery of the e-Pharmacovigilance Training in collaboration with VMD International Team and Training Centre).
13. Contribute to the planning and implementation of the Pharmacovigilance electronic system and databases.
14. Deputising for the Head of Team when needed to report to internal decision-making groups ( �Alert Meeting, LBFG, VPC). Plan and deliver presentations to external stakeholders ( NOAH and QUINS Pharmacovigilance subgroups) and participate in relevant international and national committees, meetings and working groups.
15. Support the Head of Team in taking forward opportunities for global collaboration and work-sharing across regulatory jurisdictions regarding Pharmacovigilance and promoting VMD as a leading regulator. �
16. Based on your extensive regulatory and technical expertise, provide technical and scientific leadership on Pharmacovigilance for veterinary medicines and veterinary matters (including ensuring the continued availability of veterinary medicines) to both internal and external stakeholders. Be a point of contact for external queries on matters relating to Signal Detection and Benefit Risk Assessment.�
17. Establish enhanced external regulatory and scientific networks including with other medicines regulators, and external stakeholders to build effective alliances to deliver mutually beneficial outcomes and develop the team expertise. �
18. Determine priorities and organising resources to ensure the quality of the service provided by the team to others within VMD and to stakeholders including compliance with appropriate legislation, business priorities, hot topics and published standards. ��
19. Implement the changes to Pharmacovigilance activities arising from revised legislation in GB and NI and subsequent quality management realising process / business improvements and efficiencies. Internal QMS� production of documentation and review of systems/ processes/documentation.
20. Communications/ Engagement: including response to FOIs or ministerial correspondence/ response to Urgent Safety Signals and EMA Non-Urgent Information requests.
21. Publications: social media/ Safety Updates/ Articles - Provide clinical/technical/scientific input into the content of timely and effective safety communications to other regulators, healthcare professionals, companies, and other stakeholders.�
22. Horizon scanning for new/emerging technologies, active substances and diseases; identifying associated regulatory and/or scientific gaps and new ethical considerations to facilitate innovation and minimise risk through risk management plans/ Post Authorisation Studies.
23. Actively supporting the VMD R&D programme by sponsoring research programmes and/or providing scientific critique.
24. Comply with ISO 9001 (quality management) and ISO 27001 (information security) standards, and GDPR and record management requirements.
25. Act corporately � meeting, role-modelling, embedding, and championing the corporate objectives set by the VMD.
Person specification
Candidates must have the experience and qualifications set out below:
You must have a good understanding and relevant experience in the regulation of medicinal products, an understanding of the legislative process and of the wider regulatory environment and be a good communicator. You will need to demonstrate experience in:
26. clinical, regulatory, and/or pharmaceutical sector (at least 4 years).
27. analysing and accurately interpreting data from various sources to support decisions.
28. presenting reasonable conclusions from a wide range of complex and sometimes incomplete evidence.
29. in depth knowledge and/or experience of relevant regulations and procedures applicable to veterinary medicinal products to improve the team capability for benefit risk evaluation and safety and surveillance function.
30. experience of critically analysing complex clinical/scientific/technical information from a number of sources under pressure and make appropriate recommendations or decisions to protect animal and public health and the environment even when the evidence is not clear.
31. promoting and drive continuous improvement on pharmacovigilance and risk-management topics and communication.
32. lead on the development of accurate and informative Ministerial submissions, Enquiries, Freedom of Information requests and press enquiries, relating to benefit/risk evaluations, sometimes to tight deadlines.
33. providing advice of complex issues in a way that is easy to understand.
34. management of key business processes subject to demanding deadlines and managing conflicting priorities.
35. developing business relationships.
36. providing strategic leadership.
You must also have experience in or awareness of, or a demonstrable ability to get up to speed rapidly:
37. extensive knowledge of GB VMR, post marketing monitoring systems for authorised veterinary medicines.
38. an understanding of EU 2019/6 as it applies in NI.
39. an understanding of the processes bringing about legislative change.
IT Skills
You must be proficient in the use of Microsoft Office packages, particularly Word, Excel and Outlook. You must use the internet effectively and have the aptitude to learn how to use the VMD�s bespoke IT systems and work following Agile methodology.
Qualifications
�A degree in Veterinary Science and practical clinical experience of the use of veterinary medicinal products in the different species.
�Proof of maintaining an up to date knowledge of Pharmacovigilance practice, regulations and current hot topics.
Memberships
MRCVS (Member of the Royal College of Veterinary Surgeons, London. UK)
Behaviours
We'll assess you against these behaviours during the selection process:
40. Making Effective Decisions
41. Communicating and Influencing
42. Changing and Improving
43. Seeing the Big Picture
We only ask for evidence of these behaviours on your application form:
44. Making Effective Decisions
45. Communicating and Influencing
46. Changing and Improving
Technical skills
We'll assess you against these technical skills during the selection process:
47. Knowledge of veterinary medicinal products regulations and Benefit Risk evaluation, and experience of critically analysing complex clinical/ scientific/ technical information from a number of sources and make appropriate decisions.
Benefits
Alongside your salary of �59,900, Veterinary Medicines Directorate contributes �17,353 towards you being a member of the Civil Service Defined Benefit Pension scheme.
48. Learning and development tailored to your role.
49. An environment with flexible working options.
50. A culture encouraging inclusion and diversity.
51. A with an employer contribution of
52. Free onsite parking.
53. Free eyesight test.
54. Onsite gym.
55. Access to a prayer room.