Pharmacovigilance Administrative Officer
| Posting date: | 01 May 2024 |
|---|---|
| Salary: | £27,245 per year |
| Hours: | Full time |
| Closing date: | 29 May 2024 |
| Location: | KT15 3LS |
| Company: | Government Recruitment Service |
| Job type: | Permanent |
| Job reference: | 345812/1 |
Summary
The job holder is responsible for overseeing the progression of adverse events reports subject to published standards targets for pharmacovigilance work, as set out in the VMD Business Plan.
These is a busy, complex role and requires the ability to problem solve, to prioritise and organise and collaborate with colleagues when managing the work. It is essential that the job holder can think on his/her feet, proactively keep up to date on business changes and rise to challenges quickly and effectively, whilst positively communicating and sharing understanding of processes with the rest of the team.
The post requires the individual to work within clearly defined rules, regulations and policies and the outputs are guided by practice and precedent. However, following Brexit, ongoing political uncertainty and legislation review the policies continue to change and new precedents emerge. The job holder is a primary contact for members of the pharmaceutical industry, and involves communicating with internal assessors, other global country national regulatory body representatives and the pharmaceutical industry.
The main purpose of this post is to input and process individual adverse event reports received from members of the public, veterinary surgeons, pharmaceutical companies and other government departments.
Main Duties
- Receiving, entering and checking initial and follow up reports of suspected adverse events in animals, humans or the environment following use of veterinary medicines received spontaneously into a web-based database. This includes carrying out searches to identify missing reports and eliminate duplicate reports, and some use of a dictionary of veterinary terms. It may also involve simple calculations of dosages.
- Approving and sending reports electronically to (MAHs) Marketing Authorisation Holders (and the central European database). Also periodically sending reports to the Health and Safety Executive.
- Communicating with reporters to check details or obtain additional information. This may include requesting medical reports from GPs and hospital practitioners.
- Periodically liaising with VMD Safety Team Assessor and other Government Agencies in relation to Environmental incidents.
- Monitoring two shared inboxes.
- Sending acknowledgement letters for paper adverse event forms.
- Dealing with email and telephone queries from veterinarians, doctors, the general public and the Marketing Authorisation Holders (MAHs)/Industry as well as other VMD departments in accordance with the VMD Customer Service Charter. Some queries will need to be collaborated with or escalated to the PhV Pharmacovigilance Executive Officer (EO), Assessors or Head of Team.
- Ensuring that all documents are electronically filed according to standard operating procedures.
- Maintaining a spreadsheet of MAH contact list.
- Maintaining all desk instructions and standard operating procedures relevant to the post.
- Covering EO duties in the absence, including circulating Alert Group meeting papers, reporting monthly KPI figures and covering the main PhV telephone extension.
- 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.