Pharmacovigilance Manager (2128023CM)

Do you have an eye for detail and an interest in healthcare research?

The Southampton Clinical Trials Unit (SCTU) has an exciting opportunity to join our quality team as a Pharmacovigilance Manager.

In this role you will be working within an industry-leading trials unit, with expertise in the design, conduct and publication of multicentre, interventional clinical trials and other well-designed studies.

This role will see you working with the PV and Coding Officer to ensure the pharmacovigilance programme for the SCTU meets regulatory requirements and the operational needs of the trials. 

You will ideally have experience of working in the NHS or an academic healthcare research setting. You will primarily be responsible for the pharmacovigilance programme ensuring safety events are reported to regulatory deadlines, additionally reviewing documents, writing SOPs and advising on safety reporting. Knowledge of coding concepts and MedDRA would be an advantage.

As an employee of the University of Southampton you will enjoy a competitive salary and a generous benefits package which includes:

A generous holiday entitlement, including bank holidays and university closure days per year.Qualification for the USS pension scheme, with large employer contributions to your pension. Employee benefits such as the access to the Cycle to Work Scheme, the new Low Emissions Car Scheme, and University discounts at hundreds of shops, services and businesses across the south.

This position is offered on a full time, fixed term basis for 24 months in the first instance, with the possibility of further extension. 

The Southampton Clinical Trials Unit is a UKCRC registered CTU and is core-funded by the National Institute for Health Research (NIHR) and Cancer Research UK (CRUK). We are located within the state-of-the-art Centre for Cancer Immunology building at Southampton General Hospital. At this time we are working in a hybrid manner, with a blend of home and office working.

Our trials cover the complete spectrum of clinical practice, from primary care through to tertiary referral medicine, including cancer care, experimental therapeutics, surgery, supportive care and prevention.  Undertaking multi-centre early and late phase clinical trials, we work nationally and internationally to create the evidence for patient benefit that will directly influence routine clinical practice in the NHS and overseas. 

As part of the NIHR and CRUK infrastructure we have close working relationships with our partners, including the Southampton CRUK Centre and Experimental Cancer Research Centre and NIHR partners across Wessex such as the NIHR Research Design Service, NIHR Clinical Research Network, Clinical Research Facility, Biomedical Research Centre, the Wessex Institute and University Hospital Southampton.

For informal queries please contact Sara Yeats, Senior Quality Assurance Manager, s.a.yeats@soton.ac.uk

Application Procedure:

You should submit your completed online application form at https://jobs.soton.ac.uk. The application deadline will be midnight on the closing date stated above. If you need any assistance, please call Jane Sturgeon (HR Recruitment Team) on +44 (0) 23 8059 4043 or email recruitment@soton.ac.uk  Please quote reference 2128023CM on all correspondence. 

 

Closing Date: 03 Feb 2023

Section: Management, Specialist & Administrative

Salary: £33,314 to £40,931 Per annum
Full Time Fixed Term for 24 months