Senior Pharmacovigilance Officer

4 days ago


Sutton, United Kingdom The Royal Marsden NHS Foundation Trust Full time

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:

- Ensure that all safety events across the clinical research portfolio are identified, recorded and reported.
- Coordinate and perform pharmacovigilance audits.
- Review and understand highly complex clinical research protocols and assess these for compliance to the UK Clinical Trials Regulations pertaining to pharmacovigilance.
- 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.
- 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.
- Line manage, mentor and supervise the work of the Pharmacovigilance Officer.

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.

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.

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 r



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