Job summary
We are seeking a new Senior Pharmacovigilance Officer, and there has never been a more exciting time to join us at The Royal Marsden and the Institute of Cancer Research (ICR).
What you will do:
The role is responsible for the central coordination of pharmacovigilance activity, maintaining systems for identifying, recording and reporting safety data in clinical trials undertaken by The Royal Marsden and the ICR n compliance with the UK Clinical Trials Regulations. The post-holder will:
o Ensure that all safety events across the clinical research portfolio are identified, recorded and reported.o Coordinate and perform pharmacovigilance audits.o Review and understand highly complex clinical research protocols and assess these for compliance to the UK Clinical Trials Regulations pertaining to pharmacovigilance.o Contribute to ensuring that, as far as possible, The Royal Marsden and the ICR remain 'inspection ready'. Take a key role in preparing both organisations for statutory MHRA inspections and will work towards positioning us as a leader in quality/compliance in cancer research. o Act as the expert for The Royal Marsden and the ICR for information and advice regarding pharmacovigilance, recommending and leading system change and development, and sitting on relevant committees.o Line manage, mentor and supervise the work of the Pharmacovigilance Officer.
Main duties of the job
The Senior Pharmacovigilance Officer is a senior member of the Joint Clinical Research & Development Core Services team, sitting within the The Royal Marsden's Clinical Research Directorate. The role is responsible for the central coordination of pharmacovigilance activity, maintaining systems for identifying, recording and reporting safety data in clinical trials undertaken by The Royal Marsden and the Institute of Cancer Research in compliance with the UK Clinical Trials Regulations.
About us
The Royal Marsden NHS Foundation Trust is a world-leading cancer centre. Our role is to offer our patients the best cancer care available anywhere in the world, and to continue to make a global contribution to finding better ways of diagnosing and treating cancer. We employ over 4,500 staff in a diverse range of careers including nursing, medical, science, radiography, pharmacy, occupational therapy, finance and administrative services. We have two hospitals - one in Chelsea, London, and one in Sutton, Surrey - as well as a Medical Daycare Unit in Kingston Hospital.
At The Royal Marsden, we deal with cancer every day, so we understand how valuable life is. When people entrust their lives to us, they have the right to demand the very best. That's why the pursuit of excellence lies at the heart of everything we do.
At the heart of the hospital is our dedicated team. We offer a stimulating and dynamic working environment, a wide range of staff benefits, learning and development opportunities and clear career pathways. There are opportunities to work flexibly across a range of areas and specialities and we welcome flexible working requests from point of hire to support employees work life balance. We are looking for employees who aspire to excellence, share our values and can play a crucial role in our on-going achievements.
Job description
Job responsibilities
For further information, please refer to the Job Description/Person specification
Pharmacovigilance
- Provide support and expert advice to clinical research management teams in developing pharmacovigilance sections of new clinical trials protocols, including appropriate reference to Reference Safety Information (RSI) and safety reporting.
- Coordinate reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) and to the Medicines and Healthcare products Regulatory Agency (MHRA) and Research Ethics Committee (REC).
- Monitor pharmacovigilance identification and reporting and escalating issues when required.
- Coordinate and perform pharmacovigilance audits in preparation for Developmental Safety Update Report (DSUR) production and submission.
- Inform members of the wider Joint Clinical Research & Development Core Services team about ongoing safety-related activities and compliance issues identified as part of
Leadership, management and business oversight
- Line manage, mentor and supervise the work of the Pharmacovigilance Officer
- Monitor and evaluate individual performance through the appraisal process and to ensure that appropriate action is taken to improve performance where deficits are identified.
- Provide professional leadership and line management to the members of the quality function. Ensuring continued professional development through appraisal, identification of skill gaps and by facilitating access to appropriate training opportunities.
- Actively contribute to maintaining and building a high performing quality function that ensures the highest standards of research governance across The Royal Marsden and the ICR.
Education and training
- To keep abreast of new developments and/or requirements within clinical research and disseminate changes to clinical research delivery and management teams by way of presentations and/or group meetings.
- To lead the design and delivery of all training necessary to ensure high standards and regulatory compliance across all staff groups working on the clinical research portfolio, this includes leading development of specific training according to demand.
Other responsibilities
Other duties include but are not restricted to:
- Assist in the preparation for audits or statutory inspection by the MHRA or any other body and assist in the implementation of any corrective plans.
- Preparation and/or review of trial-related reports internally and for various organisations, e.g. CRUK, MRC.
- Develop links with external national bodies and trial related groups to ensure that the views of the joint institution are represented.
- Manage own workload, determining relative priorities for action the majority of the time.
- Responsible for maintaining own professional development and be aware of current practices and future developments within The Royal Marsden and wider NHS system
Job description
Job responsibilities
For further information, please refer to the Job Description/Person specification
Pharmacovigilance
- Provide support and expert advice to clinical research management teams in developing pharmacovigilance sections of new clinical trials protocols, including appropriate reference to Reference Safety Information (RSI) and safety reporting.
- Coordinate reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) and to the Medicines and Healthcare products Regulatory Agency (MHRA) and Research Ethics Committee (REC).
- Monitor pharmacovigilance identification and reporting and escalating issues when required.
- Coordinate and perform pharmacovigilance audits in preparation for Developmental Safety Update Report (DSUR) production and submission.
- Inform members of the wider Joint Clinical Research & Development Core Services team about ongoing safety-related activities and compliance issues identified as part of
Leadership, management and business oversight
- Line manage, mentor and supervise the work of the Pharmacovigilance Officer
- Monitor and evaluate individual performance through the appraisal process and to ensure that appropriate action is taken to improve performance where deficits are identified.
- Provide professional leadership and line management to the members of the quality function. Ensuring continued professional development through appraisal, identification of skill gaps and by facilitating access to appropriate training opportunities.
- Actively contribute to maintaining and building a high performing quality function that ensures the highest standards of research governance across The Royal Marsden and the ICR.
Education and training
- To keep abreast of new developments and/or requirements within clinical research and disseminate changes to clinical research delivery and management teams by way of presentations and/or group meetings.
- To lead the design and delivery of all training necessary to ensure high standards and regulatory compliance across all staff groups working on the clinical research portfolio, this includes leading development of specific training according to demand.
Other responsibilities
Other duties include but are not restricted to:
- Assist in the preparation for audits or statutory inspection by the MHRA or any other body and assist in the implementation of any corrective plans.
- Preparation and/or review of trial-related reports internally and for various organisations, e.g. CRUK, MRC.
- Develop links with external national bodies and trial related groups to ensure that the views of the joint institution are represented.
- Manage own workload, determining relative priorities for action the majority of the time.
- Responsible for maintaining own professional development and be aware of current practices and future developments within The Royal Marsden and wider NHS system
Person Specification
Education/Qualifications
Essential
- Degree qualification (e.g. BSc) in a relevant subject.
- Recognised Good Clinical Practice certification
- Commitment to continued professional development.
Desirable
- Higher degree qualification (e.g. MSc) in a relevant subject.
- Project management qualification (e.g. PRINCE 2).
- People management and leadership qualification
Experience
Essential
- Significant experience of pharmacovigilance activities.
- Experience of working to the UK Clinical Trials Regulations
- Experience of working in an NHS or HEI environment in a quality role, including monitoring or auditing of clinical trials
- Experience of working with staff from a range of backgrounds and different levels of seniority
Desirable
- Experience of developing a strong culture of customer service
- Experience of working across organisations.
- Experience of delivering training sessions
- Experience of project management.
Skills / knowledge
Essential
- Sound knowledge of the UK Policy Framework, the Medicines for Human Use (Clinical Trials) Regulations 2004 as amended, and Guidelines for Good Clinical Practice (GCP), and the ability to interpret these in a non-commercial environment.
- Ability to work constructively as an individual; as part of a closeknit team; and as part of a wider research community.
- Ability to summarise and explain complex issues to both technical and non-technical audiences.
- Willing and able to coach and train others.
- Ability to work in a proactive manner to identify new risks and issues and flag upwards appropriately.
- Excellent communication, persuasion, listening and strong interpersonal skills as well as attention to detail and a sharp analytical mind and an ability to think laterally.
- Able to work under pressure, methodical in approach, with effective problem-solving ability
- Excellent IT literacy: evidence of competence with MS Office, particularly Excel, Word, PowerPoint, Teams and Access.
Person Specification
Education/Qualifications
Essential
- Degree qualification (e.g. BSc) in a relevant subject.
- Recognised Good Clinical Practice certification
- Commitment to continued professional development.
Desirable
- Higher degree qualification (e.g. MSc) in a relevant subject.
- Project management qualification (e.g. PRINCE 2).
- People management and leadership qualification
Experience
Essential
- Significant experience of pharmacovigilance activities.
- Experience of working to the UK Clinical Trials Regulations
- Experience of working in an NHS or HEI environment in a quality role, including monitoring or auditing of clinical trials
- Experience of working with staff from a range of backgrounds and different levels of seniority
Desirable
- Experience of developing a strong culture of customer service
- Experience of working across organisations.
- Experience of delivering training sessions
- Experience of project management.
Skills / knowledge
Essential
- Sound knowledge of the UK Policy Framework, the Medicines for Human Use (Clinical Trials) Regulations 2004 as amended, and Guidelines for Good Clinical Practice (GCP), and the ability to interpret these in a non-commercial environment.
- Ability to work constructively as an individual; as part of a closeknit team; and as part of a wider research community.
- Ability to summarise and explain complex issues to both technical and non-technical audiences.
- Willing and able to coach and train others.
- Ability to work in a proactive manner to identify new risks and issues and flag upwards appropriately.
- Excellent communication, persuasion, listening and strong interpersonal skills as well as attention to detail and a sharp analytical mind and an ability to think laterally.
- Able to work under pressure, methodical in approach, with effective problem-solving ability
- Excellent IT literacy: evidence of competence with MS Office, particularly Excel, Word, PowerPoint, Teams and Access.
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 (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
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 (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
