Specialist Pharmacist – Production and Clinical Trials inNottingham inNottingham PUBLISHED 4 NOV 2024
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An opportunity has arisen within the Pharmacy Production Management Team for a specialist pharmacist toassist 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 allfour 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
JOB SUMMARY
Assist in the overall management & development of Pharmacy Technical Services.
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.
Assist in the development and management of advanced therapy services for the treatment of NUH patients.
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.
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.
About usKEY JOB RESPONSIBILITIES
Production/Technical & Clinical Trial Services
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. To maintain an awareness and knowledge of new medicines, advances in treatment and service developments to inform workload and workforce planning. This includes being an active member of the NUH Pharmacy Clinical Trial services team and via liaison with a variety of study co-ordinators and clinicians.
4. To deputise for the Assistant Head of Pharmacy Production Services and to provide professional advice and support to the various sections in the Pharmacy Production Department.
5. To support and supervise a team of Pharmacists, Pre-registration Pharmacists, Scientific and other support staff in undertaking their day-to-day operational activities.
6. To maintain awareness and knowledge of industry development and best practice, ensuring that a comprehensive and up-date selection of reference texts and journals is maintained.
7. To maintain and further develop, where appropriate, links with relevant professional bodies and organisations e.g., General Pharmaceutical Council, MHRA, Department of Health, NIHR and research networks inclu
8. To liaise with QC on a regular basis over all aspects of quality assurance to ensure that production activities comply with the Rules & Guidance for Pharmaceutical Manufacturers & Distributors, Good Clinical Practice Guide, Quality Assurance Of Aseptic Preparation Services for activities under section 10 exemption of Medicines Act, and any other appropriate legislative, DoH guidance documents as well as local policies and procedures. To carry out internal audit and report on findings at the appropriate forum. To engage in all aspects of the Quality Management System within the Pharmacy Production Department.
9. To conduct and/or contribute to relevant clinical and other audits to facilitate clinical governance requirements. To reflect on and interpret the results of audits, address remedial points and implement change as required.
10. To assist in identifying staffing and recruitment issues and implementing change in the staff structure to accommodate change in service needs and / or to resolve issues. To evaluate the effect changes in workload, staffing and service development (capacity planning) have on service delivery and to ensure that appropriate actions are applied to ensure that the services operate at low risk to patients at all times. To participate in recruitment as required.
11. To critically appraise published work in responding to questions raised by other health-care professionals including other pharmacists, and offer advice on conflicting or absent information.
12. To accurately interpret clinical trial and investigational medicinal product requests and requirements, intervening when necessary by raising queries with the appropriate investigator.
13. To ensure that trial requests are dealt with in a timely manner according to agreed performance indicators.
14. To assist in the production and management of the documentation system required in the Department, ensuring the maintenance of all necessary record entries and audit processes, particularly with reference to trial documentation.
15. To assist in the maintenance of the Validation Master Plan across the production unit to ensure its continuing development and validity.
16. To contribute to the submission of business cases to secure funding for new pharmacy staff, equipment, premises or services for the advancement of Pharmacy Technical Services with specific reference to clinical trial activity.
17. To assist in the management of the overall stock control systems and to contribute to the overall modernisation of Pharmacy Technical Services, including proposals, business cases and implementation of new systems.
18. To assist in the formal management of contracts with external customers, focussing on those concerned with trial activity.
19. To support Health and Safety assessment and evaluation, including COSHH, for Pharmacy Technical Services and to participate in the Pharmacy Health and Safety management team.
20. To support the Assistant Head of Pharmacy Production Services in the development and delivery of timely performance reports. To develop performance indicators that clearly demonstrate the contribution that staff working on clinical trial projects make to patient care and to the trial portfolio within the Pharmacy Production Department
21. To provide professional support to the Production Management team and act as an authorised pharmacist and validated checker as demanded by legal requirements.
22. To support the Head of Pharmacy in specific pharmacy management issues and projects and to contribute to the overall organisation, administration and management of the NUH Pharmacy department e.g. rota management, workload analysis and staff deployment.
Advanced Therapies
- Advise and support NUH services on how to deliver novel advanced therapy services including those in clinical trials.
- Be an active member of the Genetically Modified-Organism Safety Committee, giving advice from a pharmaceutical and GCP perspective.
- Support the Principal Pharmacist for Research and Innovative Treatments with the implementation and development of the Advanced Therapy Medicinal Product (ATMP) service. Assisting with the development, implementation and maintenance of an effective Quality Management System (QMS) for ATMPs and assisting with review of advanced therapy risk.
- Implement and review standard operating procedures in relation to pharmacy delivery of advanced therapy services. Support and advise on other aspects of advanced therapy service delivery outside of pharmacy.
- Responsible for the day to day management of the Pharmacy ATMP service provided at NUH.
- Manage the activities of and team delivery of Advanced Therapy Investigational Medicinal Product (ATIMP) clinical trials.
- Support the Prinicipal Phamacist for R&I in maintaining and developing the ATIMP clinical trials service to ensure the smooth running of clinical trials within this field.
- Provide support and advice to the technical services team with regards to ATMPs and ATIMPs.
- If necessary complete Biosafety Practitioner Level 1 training.
Education and Training
1. To take a lead role in the development, introduction, implementation, training and evaluation of new technologies in relation to Pharmacy Production with a clinical trials focus. In conjunction with production and quality control staff and the pharmacy departments training team, to ensure that all staff (including Resident Pharmacists and Pre registration pharmacists) who undertake production activities within the Production Departments possess the necessary skills to do so safely. This involves ensuring their training and competency assessment is effectively carried out. In conjunction with the lead production training technician to regularly review and update training packages to reflect current best practice and latest evidence.
2. To take an active lead role in the specialist teaching and training to nurses, pharmacists, doctors and other healthcare staff on technical matters and to deliver specialist education and training to audiences both within and outside Pharmacy and the Trust. This may include undergraduate and post-graduate medicine, pharmacy degree, pre-registration and diploma courses and non-medical prescribing courses.
3. To initiate and participate in research and to supervise research projects and developments in production facilities, equipment and services and publish results if appropriate.
4. To undertake and document continuing professional development according to departmental policy and to maintain a portfolio of practice including maintenance of GCP accreditation. To attend courses relevant to technical pharmacy and to feedback any relevant information so as to provide benefits to the pharmacy service
General clinical duties
It is intended that the role of Specialist Pharmacist Pharmacy Production and Clinical Trials would not routinely undertake day to day ward based clinical pharmacy duties. The clinical duties included below are here if, by mutual agreement between post holder and line manager, the post holder desired to have/maintain a clinical pharmacy commitment.
1. To work with the clinical pharmacy team in the provision of a high quality clinical pharmacy service to wards and other areas of pharmacy when required. To participate in an appropriate departmental committee/working group in order to effectively represent clinical pharmacy services and to contribute to the development of services for patients
2. To assess prescriptions in order to ensure safe rational and effective prescribing, establishing drug histories, enabling use of patients own medicines and patient self-administration, and counselling to improve medication usage and patient understanding during in patient stay or at discharge To professionally screen, dispense, and check prescriptions in accordance with professional and local procedures, in order to ensure the safe and cost-effective delivery of medicines to patients
3. To interpret and request clinical tests to monitor and make recommendations to improve effectiveness of drug therapy
4.To make recommendations about medications to improve patient outcomes and to encourage adherence to hospital formulary and national guidelines
5. To provide medications for individual patients during their stay in hospital and at discharge
An opportunity has arisen within the Pharmacy Production Management Team for a specialist pharmacist toassist 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 allfour 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
JOB SUMMARY
Assist in the overall management & development of Pharmacy Technical Services.
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.
Assist in the development and management of advanced therapy services for the treatment of NUH patients.
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.
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.
About us
KEY JOB RESPONSIBILITIES
Production/Technical & Clinical Trial Services
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. To maintain an awareness and knowledge of new medicines, advances in treatment and service developments to inform workload and workforce planning. This includes being an active member of the NUH Pharmacy Clinical Trial services team and via liaison with a variety of study co-ordinators and clinicians.
4. To deputise for the Assistant Head of Pharmacy Production Services and to provide professional advice and support to the various sections in the Pharmacy Production Department.
5. To support and supervise a team of Pharmacists, Pre-registration Pharmacists, Scientific and other support staff in undertaking their day-to-day operational activities.
6. To maintain awareness and knowledge of industry development and best practice, ensuring that a comprehensive and up-date selection of reference texts and journals is maintained.
7. To maintain and further develop, where appropriate, links with relevant professional bodies and organisations e.g., General Pharmaceutical Council, MHRA, Department of Health, NIHR and research networks inclu
8. To liaise with QC on a regular basis over all aspects of quality assurance to ensure that production activities comply with the Rules & Guidance for Pharmaceutical Manufacturers & Distributors, Good Clinical Practice Guide, Quality Assurance Of Aseptic Preparation Services for activities under section 10 exemption of Medicines Act, and any other appropriate legislative, DoH guidance documents as well as local policies and procedures. To carry out internal audit and report on findings at the appropriate forum. To engage in all aspects of the Quality Management System within the Pharmacy Production Department.
9. To conduct and/or contribute to relevant clinical and other audits to facilitate clinical governance requirements. To reflect on and interpret the results of audits, address remedial points and implement change as required.
10. To assist in identifying staffing and recruitment issues and implementing change in the staff structure to accommodate change in service needs and / or to resolve issues. To evaluate the effect changes in workload, staffing and service development (capacity planning) have on service delivery and to ensure that appropriate actions are applied to ensure that the services operate at low risk to patients at all times. To participate in recruitment as required.
11. To critically appraise published work in responding to questions raised by other health-care professionals including other pharmacists, and offer advice on conflicting or absent information.
12. To accurately interpret clinical trial and investigational medicinal product requests and requirements, intervening when necessary by raising queries with the appropriate investigator.
13. To ensure that trial requests are dealt with in a timely manner according to agreed performance indicators.
14. To assist in the production and management of the documentation system required in the Department, ensuring the maintenance of all necessary record entries and audit processes, particularly with reference to trial documentation.
15. To assist in the maintenance of the Validation Master Plan across the production unit to ensure its continuing development and validity.
16. To contribute to the submission of business cases to secure funding for new pharmacy staff, equipment, premises or services for the advancement of Pharmacy Technical Services with specific reference to clinical trial activity.
17. To assist in the management of the overall stock control systems and to contribute to the overall modernisation of Pharmacy Technical Services, including proposals, business cases and implementation of new systems.
18. To assist in the formal management of contracts with external customers, focussing on those concerned with trial activity.
19. To support Health and Safety assessment and evaluation, including COSHH, for Pharmacy Technical Services and to participate in the Pharmacy Health and Safety management team.
20. To support the Assistant Head of Pharmacy Production Services in the development and delivery of timely performance reports. To develop performance indicators that clearly demonstrate the contribution that staff working on clinical trial projects make to patient care and to the trial portfolio within the Pharmacy Production Department
21. To provide professional support to the Production Management team and act as an authorised pharmacist and validated checker as demanded by legal requirements.
22. To support the Head of Pharmacy in specific pharmacy management issues and projects and to contribute to the overall organisation, administration and management of the NUH Pharmacy department e.g. rota management, workload analysis and staff deployment.
Advanced Therapies
- Advise and support NUH services on how to deliver novel advanced therapy services including those in clinical trials.
- Be an active member of the Genetically Modified-Organism Safety Committee, giving advice from a pharmaceutical and GCP perspective.
- Support the Principal Pharmacist for Research and Innovative Treatments with the implementation and development of the Advanced Therapy Medicinal Product (ATMP) service. Assisting with the development, implementation and maintenance of an effective Quality Management System (QMS) for ATMPs and assisting with review of advanced therapy risk.
- Implement and review standard operating procedures in relation to pharmacy delivery of advanced therapy services. Support and advise on other aspects of advanced therapy service delivery outside of pharmacy.
- Responsible for the day to day management of the Pharmacy ATMP service provided at NUH.
- Manage the activities of and team delivery of Advanced Therapy Investigational Medicinal Product (ATIMP) clinical trials.
- Support the Prinicipal Phamacist for R&I in maintaining and developing the ATIMP clinical trials service to ensure the smooth running of clinical trials within this field.
- Provide support and advice to the technical services team with regards to ATMPs and ATIMPs.
- If necessary complete Biosafety Practitioner Level 1 training.
Education and Training
1. To take a lead role in the development, introduction, implementation, training and evaluation of new technologies in relation to Pharmacy Production with a clinical trials focus. In conjunction with production and quality control staff and the pharmacy departments training team, to ensure that all staff (including Resident Pharmacists and Pre registration pharmacists) who undertake production activities within the Production Departments possess the necessary skills to do so safely. This involves ensuring their training and competency assessment is effectively carried out. In conjunction with the lead production training technician to regularly review and update training packages to reflect current best practice and latest evidence.
2. To take an active lead role in the specialist teaching and training to nurses, pharmacists, doctors and other healthcare staff on technical matters and to deliver specialist education and training to audiences both within and outside Pharmacy and the Trust. This may include undergraduate and post-graduate medicine, pharmacy degree, pre-registration and diploma courses and non-medical prescribing courses.
3. To initiate and participate in research and to supervise research projects and developments in production facilities, equipment and services and publish results if appropriate.
4. To undertake and document continuing professional development according to departmental policy and to maintain a portfolio of practice including maintenance of GCP accreditation. To attend courses relevant to technical pharmacy and to feedback any relevant information so as to provide benefits to the pharmacy service
General clinical duties
It is intended that the role of Specialist Pharmacist Pharmacy Production and Clinical Trials would not routinely undertake day to day ward based clinical pharmacy duties. The clinical duties included below are here if, by mutual agreement between post holder and line manager, the post holder desired to have/maintain a clinical pharmacy commitment.
1. To work with the clinical pharmacy team in the provision of a high quality clinical pharmacy service to wards and other areas of pharmacy when required. To participate in an appropriate departmental committee/working group in order to effectively represent clinical pharmacy services and to contribute to the development of services for patients
2. To assess prescriptions in order to ensure safe rational and effective prescribing, establishing drug histories, enabling use of patients own medicines and patient self-administration, and counselling to improve medication usage and patient understanding during in patient stay or at discharge To professionally screen, dispense, and check prescriptions in accordance with professional and local procedures, in order to ensure the safe and cost-effective delivery of medicines to patients
3. To interpret and request clinical tests to monitor and make recommendations to improve effectiveness of drug therapy
4.To make recommendations about medications to improve patient outcomes and to encourage adherence to hospital formulary and national guidelines
5. To provide medications for individual patients during their stay in hospital and at discharge
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