Pharmacovigilance (PV) Manager - Cancer Research UK Clinical Trials Unit - 105539 - Grade 8

University of Birmingham; Birmingham; On-site; GBP 46,000 - 56,000

Job description

Position Details

Cancer Research UK Clinical Trials Unit, School of Medical Sciences, College of Medicine and Health

Location: University of Birmingham, Edgbaston, Birmingham UK

Full time starting salary is normally in the range £46,735 to £55,755 with potential progression once in post to £62,728

Grade: 8

Full Time, Permanent

Closing date: 21st April 2025

Our offer to you

People are at the heart of what we are and do. The University of Birmingham is proud to have been a part of the City of Birmingham and the wider region for over 100 years, and we are equally proud to be recognised as a leading global university. We want to attract talented people from across the city and beyond, support them to succeed, and celebrate their success.

We are committed to helping the people who work here to develop through our sector-leading Birmingham Professional programme which provides all professional services staff with development opportunities and the encouragement to reach their full potential. Supporting our people to achieve a healthy work/life balance is important both to our employees and to the success of the University and, depending on the role, we offer a variety of flexible working arrangements. We therefore welcome discussions on all forms of flexible working. In addition, you will receive a generous package of benefits including 40 days paid holiday a year, one paid day a year for volunteering, occupational sick pay, and a pension scheme.

Background

The Cancer Research UK Clinical Trials Unit (CRCTU) is one of two UK Clinical Research Collaboration (UKCRC) registered clinical trials units (CTUs) at the UoB. The CRCTU was established over 50 years ago and is now an integral part of the School of Medical Sciences. It has grown to be one of the largest cancer specialist trials units in the UK, delivering high quality clinical research across a broad portfolio of disease types and treatment modalities in all phases of clinical trials.

Role Summary

An integral part of clinical trials involves the collection, analysis and reporting of safety information and adverse events including adverse reactions and the identification of any event that is serious and unexpected. It is essential that cases are assessed and reported appropriately in compliance with applicable legislation.

The post holder will lead on pharmacovigilance (PV) and safety reporting within the CRCTU working closely with the CRCTU Director of Operations to develop and maintain appropriate systems and to meet reporting requirements.

Main Duties

Leadership and management duties

• Lead on PV and safety reporting ensuring that regulatory timelines are met.
• Lead and motivate staff responsible for the day-to-day conduct of PV activities.
• Develop processes for safety reporting, write, and review Standard Operating Procedures (SOPs) and supporting documents.
• Maintain an overview of SAE reporting within the Unit, ensuring regulatory timelines are met and SOPs followed.
• Regularly review safety reporting activity and systems within and across CRCTU trials, identifying any patterns, concerns or inefficiencies.
• Provide specialist advice to staff and stakeholders.
• Represent the Unit in audits and inspections regarding PV activities.
• Prepare and present reports on PV activities including regulatory compliance to the CRCTU Operational Management Committee and others as required.

Required Knowledge, Skills, Qualifications, Experience

Essential

• Education to BSc level in a biomedical or a related sciences subject, or other relevant qualification.
• Experience of PV/safety reporting activities in CTIMPs including assessment of SAEs, regulatory reporting to competent authorities and ethics committees.
• Experience of providing training in a clinical trial management setting.
• Excellent communication skills.
• Support the delivery of clinical research in accordance with Good Clinical Practice (GCP), the Declaration of Helsinki, applicable legislation.

Desirable

• Post-graduate PV qualification.
• Experience of early phase oncology clinical trials.

Core competencies/transferable skills

• Planning and organising: provide professional expertise, and manage resources and/or a diverse team.
• Problem solving and decision making: anticipate, interpret and assess customer needs, identifying trends, generating original ideas and testing innovative solutions.
• Relationships and communication: use coaching skills to motivate and develop staff.

Informal enquiries to Dr Sarah Bowden, email: [e-mail]