Pharmaceutical Assessor
| Dyddiad hysbysebu: | 02 Ebrill 2024 |
|---|---|
| Cyflog: | £35,857 i £38,551 bob blwyddyn |
| Gwybodaeth ychwanegol am y cyflog: | London: £35,857 - £38,551. |
| Oriau: | Llawn Amser |
| Dyddiad cau: | 30 Ebrill 2024 |
| Lleoliad: | KT15 3LS |
| Cwmni: | Government Recruitment Service |
| Math o swydd: | Parhaol |
| Cyfeirnod swydd: | 342075/1 |
Crynodeb
The main role of the Quality team is to assess quality data submitted by companies in support of their applications for marketing authorisations for veterinary medicines, and applications to vary these authorisations. The Quality team also has a significant role in the delivery of the VMD’s regulatory science strategy, development of regulatory and scientific guidelines aimed at the pharmaceutical industry and supporting the delivery of VMD`s international activities, which includes training other veterinary medicine regulators.
The main role of the team is:
- to assess chemistry and pharmaceutical data for applications to vary existing marketing authorisations for veterinary medicines
- collaborating with members of the Authorisations Division to achieve the Division’s overall objectives
Responsibilities and your main duties:
- scientifically assess pharmaceutical data submitted by companies in support of their variations to veterinary medicinal applications in line with legislative timelines and international guidance documents.
- as necessary, produce a written report that forms the quality section of the overall VMD assessment report for the application
- undertake a detailed evaluation of pharmaceutical data and, in liaison with other assessors, formulate a recommendation to accept or refuse the application, based on the benefits and risks you identify during the assessment
- communicate your assessments clearly to internal decision-making groups to enable them to decide whether the data satisfy regulatory requirements and to decide on a course of action
- provide regulatory and scientific advice to internal and external stakeholders
- maintain a thorough working knowledge of your own specialism and of the relevant legislation and guidelines
- contribute to the production of relevant training materials in order to pass on knowledge to other members of the VMD
- maintain internal databases/regulatory documents
- 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.
Working Pattern
This is a full-time post. It may also be possible for individuals to fill these roles on a part-time 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. Term time working would not be possible due to the short timelines assigned to the tasks and projects deadlines.