Pharmacovigilance Officer

Job description

Detailed job description and main responsibilities

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.

Person specification

Education/Qualifications

Essential criteria

• Degree in a life sciences or related discipline or equivalent experience in clinical research
• Recognised GCP training

Desirable criteria

• 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

Experience

Essential criteria

• 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 criteria

• 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

Skills, Abilities and Knowledge

Essential criteria

• 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

The Royal Marsden values diversity and is committed to the recruitment and retention of underrepresented minority groups. We particularly welcome applications from Black, Asian and minority ethnic candidates, LGBTQ+ candidates and candidates with disabilities.

As a Disability Confident Employer, we are working to create a workplace that enables all staff to reach their full potential. We are committed to this because we know that greater diversity and inclusion will lead to an even greater positive impact for the people we serve.

Due to the high volumes of applications we receive, we reserve the right to close any adverts before the published closing date once we have received a sufficient number of applications. We advise you to submit your application as early as possible to prevent disappointment. Please ensure your information is accurate to avoid errors with processing your application

All applicants will be contacted by email to the address supplied on your application. Applicants are advised to check their email accounts regularly and to ensure that email filters are set to allow our emails.

Flu Vaccination - What We Expect of our Staff

At The Royal Marsden we have an immune compromised patient population who we must protect as much as we can against the flu virus. Each year, seasonal flu affects thousands of people in the UK. Occurring mainly in winter, it is an infectious respiratory disease capable of producing symptoms ranging from those similar to a common cold, through to very severe or even fatal disease.

The wellbeing of our staff and patients is of the upmost importance to us, and it is the expectation of The Royal Marsden that all patient-facing staff have an annual flu vaccination, provided free of charge by the Trust.

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