Specialist Pharmacist – Production and Clinical Trials
Nottingham University Hospitals NHS Trusts
An opportunity has arisen within the Pharmacy Production Management Team for a specialist pharmacist to assist in the overall management and development of pharmacy production services and to support the provision, management and development of a safe pharmacy clinical trial production and specialist clinical pharmacy service for patients within NUH and in the wider healthcare environment. This position will cover all four production units across Nottingham University Hospitals developing a more cohesive and structured service.
The production units across NUH manufacture and pack a broad range of products (sterile, aseptic, chemotherapy, non-sterile, trial material, pre-packs, ward packs etc) and their involvement in Clinical Trials is increasing rapidly. The post holder will be expected to promote the NUH Production Units as a centre of excellence to current and potential outside customers and to work to expand this area. The additional requirements of MHRA licences and Quality Management Systems require increased input at advanced level to ensure consistently high levels of practice, and development of the MIA(IMP) is crucial to deliver the department and trust objectives around research capability.
This post requires you to be a registered pharmacist with experience within a production setting. Previous experience of clinical trials would be an advantage.
Main duties of the job
JOB SUMMARY
1. Assist in the overall management & development of Pharmacy Technical Services.
2. Co-ordinate and lead all technical and research activities relating to Investigational Medicinal Products (IMPs) manufactured under the site's MHRA MIA(IMP) manufacturing authorisation.
3. Assist in the development and management of advanced therapy services for the treatment of NUH patients.
4. Support the provision, management and development of a safe pharmacy clinical trial production and specialist clinical pharmacy service for patients within NUH and in the wider healthcare environment.
5. The post holder will be based in the Production Units at the QMC Campus but a certain amount of cross campus working will be required to enable the effectiveness of this role as appropriate.
Job responsibilities
KEY JOB RESPONSIBILITIES
1. Assist in the overall management of all activities in all sections in the NUH Pharmacy Production Department to ensure services are maintained; informing the Assistant Head of Pharmacy - Production Services of workload changes likely to impact on safe working practices.
2. Final check and release medicines manufactured and prepared in NUH Pharmacy Production Units.
3. Maintain an awareness and knowledge of new medicines, advances in treatment and service developments to inform workload and workforce planning.
4. Deputise for the Assistant Head of Pharmacy Production Services and provide professional advice and support to the various sections in the Pharmacy Production Department.
5. Support and supervise a team of Pharmacists, Pre-registration Pharmacists, Scientific and other support staff in their day-to-day operational activities.
6. Maintain awareness and knowledge of industry development and best practice.
7. Maintain and further develop links with relevant professional bodies and organisations.
8. Liaise with QC on all aspects of quality assurance to ensure compliance with relevant regulations and guidelines.
9. Conduct and/or contribute to relevant clinical and other audits to facilitate clinical governance requirements.
10. Assist in identifying staffing and recruitment issues and implementing changes in the staff structure.
11. Critically appraise published work in responding to questions raised by other health-care professionals.
12. Accurately interpret clinical trial and investigational medicinal product requests and requirements.
13. Ensure that trial requests are dealt with in a timely manner according to agreed performance indicators.
14. Assist in the production and management of the documentation system required in the Department.
15. Assist in the maintenance of the Validation Master Plan across the production unit.
16. Contribute to the submission of business cases to secure funding for new pharmacy staff, equipment, premises or services.
17. Assist in the management of the overall stock control systems.
18. Assist in the formal management of contracts with external customers.
19. Support Health and Safety assessment and evaluation.
20. Support the Assistant Head of Pharmacy Production Services in the development and delivery of timely performance reports.
21. Provide professional support to the Production Management team and act as an authorised pharmacist and validated checker.
22. Support the Head of Pharmacy in specific pharmacy management issues and projects.
Person Specification
Training & Qualifications
* BPharm/BSc or MPharm/MSc or equivalent
* Current GPhC registration
* Diploma/MSc in Clinical Pharmacy, or relevant postgraduate experience
* Demonstrates continued professional development or equivalent knowledge through extensive experience
* Awareness of Good Clinical Practice (GCP)
* Attendance at relevant regional and national Clinical trials courses / meetings
* Member of relevant specialist pharmacist group
* Current GCP certification.
* Teaching/Mentoring qualifications
* Evidence of leadership qualifications
* Member of the RPharmS
Experience
* Experience of specialist clinical pharmacy service delivery
* Awareness of specialist clinical trials service delivery in pharmacy
* Experience of time management, clinical appraisal, and knowledge of Medicines Information resources and systems
* Computer literate
* Training and/or experience in clinical teaching/tutoring, audit, practice research, risk management
* Comprehensive knowledge and understanding of the formulation, preparation, therapeutic action of medicines
* Broad knowledge of therapeutics
* Comprehensive knowledge and understanding of professional and statutory requirements relating to medicines and clinical trials
* Knowledge of national disease guidelines, NICE guidance, formulary restrictions and evidence based literature
* Clinical pharmacy responsibilities at a senior level
* Experience of specialist clinical trials service delivery in pharmacy.
* Evidence of research or project work
Communication and Relationship skills
* Strong, accurate and concise written and oral communication skills
* Confident and assertive
* Able to empathise and communicate effectively with patients
* Able to receive, interpret, summarise, communicate and present complex information
* Proven ability to influence and negotiate with relevant senior clinicians, managers and key stakeholders
* Tact and diplomacy skills
* Effective independent and team working skills
* Proactive and innovative
Other requirements specific to the role
* Participation in weekend Bank Holiday and Senior back up working rotas
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service.
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