Pharmacovigilance Officer

Candidates will be required to have experience working to GCP standards and have experience also in pharmacovigilance. If the successful candidate is an internal applicant, the role will be offered as a secondment - please note line management approval must be obtained before applying. For external candidates, the position is offered on a fixed-term basis.

The Trust recognises that candidates may use artificial intelligence (AI) tools during the application process. Whilst these may be used for drafting, applicants remain wholly responsible for the accuracy, authenticity and truthfulness of all the information submitted. Applications or interview responses that include false, misleading, or unverifiable content (generated by AI or otherwise) may lead to withdrawal from the recruitment process.

For further information on the role please refer to the job description and personal specification

• To provide support and expert advice to clinical research teams in developing pharmacovigilance sections of new clinical trials protocols.
• To assist in the reporting of SUSARS and Serious Breaches to the MHRA and REC.
• To monitor pharmacovigilance processes (including for example hosted and sponsored USMs) and their reporting, and escalating issues when required.
• Co-ordinate and perform pharmacovigilance audits in preparation for Developmental Safety Update Reports (DSURS) production and submission.
• To co-ordinate and assist in the production and submission of Developmental Safety Update Reports (DSURS) to the MHRA.

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.

Essential: - Degree in a life sciences or related discipline or equivalent experience in clinical research; - Recognised GCP training

Desirable: - Degree or post-graduation in pharmacy, pharmacology, or related drug safety qualification; - Evidence of completion of pharmacovigilance course(s) with a reputable provider e.g., MedDRA coding training certificate from MSSO

Essential: - Experience of working to UK Clinical Trials Regulations in an administrative role; - Experience of working in a quality assurance / audit / monitor / pharmacovigilance / trial management role within clinical research; - Ability to read and understand clinical research protocols and associated research documents, and to critically evaluate them; - Experience of working in the NHS or relevant clinical / research environment (with non-commercial clinical trials and studies); - Proven ability to develop effective working relationships and to resolve data / quality / operational issues collaboratively; - Awareness of Adverse Events reporting requirements for CTIMPs, non-CTIMPs and CIMDs

Desirable: - Experience preparing, evaluating, and submitting Development Safety Update Reports (DSURs); - Experience preparing, evaluating, and submitting Individual Case Safety Reports (ICSRs); - Experience of developing practical, proportionate data-collection tools and processes to evaluate quality and compliance

Essential: - Ability to work in a proactive manner to identify new risks and issues, and flag these upwards appropriately; - Ability to work on own initiative, and comfortable working independently and collaboratively as part of a diverse team; - Proven ability to organise own work in busy work environment and time critical situations; - Excellent administrative and organisational skills with high level of accuracy and attention to detail; - Ability to summarise and explain complex issues to both technical and non-technical audiences both in written form and through presentations; - Excellent IT skills including Microsoft Office Suites; - Flexible to meet the needs of the service (e.g., working ad hoc to support regulatory inspections); - Able to work on both RM sites and to be flexible to meet the needs of the role