Pharmacovigilance Assessor
7 days ago
**Details**:
**Reference number**:
- 377542**Salary**:
- £44,500 - £49,020- This post is eligible for an additional pay supplement of £3,000 (pro rata) upon appointment.- A Civil Service Pension with an employer contribution of 28.97%**Job grade**:
- Senior Executive Officer- Senior Scientific Officer**Contract type**:
- Permanent**Business area**:
- Pharmacovigilance Team**Type of role**:
- Operational Delivery**Working pattern**:
- Full-time, Job share, Part-time**Number of jobs available**:
- 3Contents
Location
About the job
**Benefits**:
Things you need to know
Location
- 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.About the job
**Job summary**:
**Make a difference for animal and public health and the environment.**
As a pharmacovigilance assessor within the Pharmacovigilance Team, you will contribute to the VMD's aims and objectives by monitoring reports of suspected adverse events and lack of efficacy following use of veterinary medicinal products, in order to ensure that the benefit/risk balance of these products remains positive.
**Job description**:
**Your main duties will include**:
- Acting on behalf of the UK regulator, enabling and overseeing implementation of current veterinary medicines regulation.
- Validation, assessment and analysis of safety and efficacy data received from various sources.
- Performing individual clinical case assessment and follow-up, and quality control of marketing authorisation holder (MAH) cases.
- Peer review assessment of reports and other publications prepared by other Pharmacovigilance assessors.
- Ongoing signal detection, evaluation, benefit-risk assessment and proposal of risk minimisation measures following the team's internal signal management system.
- Internal and external enquiry responses, collaboration with Gov.uk publications including Urgent Safety Updates.
- Assessment of periodic reports, variations and rapid alerts and assisting in assessment of new authorisations.
- Collaborate in the maintenance of the team's quality management system.
- Participation in external stakeholder and international regulatory collaborative meetings.
- Collaboration in the continuous improvement and review of the pharmacovigilance IT system.
- Provide regulatory and scientific technical advice to internal and external stakeholders.
- Develop and maintain a thorough working knowledge of your own specialism and of the relevant legislation and guidelines.
- Manage and develop other assessors in the team and build capability through provision of relevant training and mentoring.
- Collaborate with members of the Authorisations Division to achieve the Division's overall objectives.
- Represent the work of the pharmacovigilance team and the VMD in national and international committees.
- Contribute to wider VMD initiatives, such as training and education, publicity programmes.
- Comply with ISO 9001 (quality management) and ISO 27001 (information security) standards, and GDPR and record management requirements.
- Act corporately - meeting, role-modelling, embedding, and championing the corporate objectives set by the VMD.
**Person specification**:
A substantial body of relevant experience is required for this post as assessor at grade SSO. An in-depth practical understanding of factors affecting the safety of medicines, for example, work in medicinal product development or work in regulatory affairs for a pharmaceutical company or in an industry that is closely related.
**Knowledge of regulatory authorisation systems for medicinal products is essential.**
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.
**Qualifications**:
- Degree as a Veterinary Surgeon, Veterinary Nursing qualification or a Scientific Degree**Memberships**:
- MRCVS for Vet Surgeons and Vet Nurses**Behaviours**:
We'll assess you against these behaviours during the selection process:
- Delivering at Pace
- Making Effective Decisions
- Working Together
- Seeing the Big Picture
**Benefits**:
- Alongside your salary of £44,500, Veterinary Medicines Directorate contributes £12,891 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides.- Learning and development tailored to your role.
- An environment with flexible working options.
- A culture encouraging inclusion and diversity.
- A Civil Service pension with an employer contribution of 28.97%.
- Free onsite parking.
- Free eyesight test.
- Onsite gym.
- Access to a prayer room.
Things you need to know
**Selection process details**:
- This vacancy is using Success Profiles (opens in a new window), and will assess your Behaviours and Experience.**Applicatio