Salary: Grade 8: £40,792 £48,677 p.a. (pro rata for part-time)
We have an exciting opportunity for a Pharmacovigilance (PV) Manager to join the Oncology Clinical Trials Office (OCTO) working on a portfolio of early and late phase trials, ranging from single centre to multicentre, multi-national trials. The post holder will work closely with the Trial Management Director, investigators and individual trial teams. The post holder will support OCTO in a wide variety of tasks including:
developing and maintaining appropriate safety reporting systems for the OCTO portfolio;
working to meet timelines on SAE data exchange with business or other collaborating partners;
supporting with the safety review of protocols, Patient Information Sheets, Consent Documents and protocol amendments where appropriate;
defining PV reporting systems in line with trial protocols, risk assessments and contracts applicable to the trials;
processing Serious Adverse Event Reports (SAEs) from clinical trials, ensuring events are followed to resolution;
fulfilling regulatory reporting requirements for SUSAR reporting to competent authorities and ethics committees in the UK and in other countries;
preparing Development Safety Update Reports;
ensuring that OCTO maintains current information on Reference Safety Information for all investigational products;
inputting to and reviewing the safety sections of Final Clinical Study Reports;
providing PV training as required to OCTO staff and participating study sites.
The successful applicant will be educated to BSc level or equivalent in a biomedical or related sciences subject and experience in a pharmacovigilance role. S/he will have experience of clinical trial management and UK clinical research structures, regulatory and ethical systems. Some travel in the UK and further afield on occasion is required, including some overnight stays.
Whilst the role is a Grade 8 position, we are willing to consider candidates with potential but less experience who are seeking a development opportunity, for which an initial appointment would be at Grade 7 (£32,236 - £39,609 p.a.) with the responsibilities adjusted accordingly. The development from Grade 7 to Grade 8 would be supported with suitable training and clear objectives and it would be expected that the progression from Grade 7 to 8 would be within 12 months. This would be discussed with applicants at interview/appointment where appropriate.
OCTO is the oncology division of the UKCRC registered Oxford Clinical Trials Research Unit (OCTRU).
This post is available for a fixed-term of 3 years. Full-time or part-time hours will be considered.
All applicants must complete an online application and upload a CV and supporting statement.
Informal enquiries may be made to: firstname.lastname@example.org.
The closing date for applications is 12.00 noon on 28 March 2019.