Pharmacovigilance (PV) Administrator
Department of Oncology, Oncology Clinical Trials Office (OCTO), Churchill Hospital, Oxford, OX3 7LE
Grade 6: £29,614- £35,326 per annum
Please note: this is a re-advertisement. Previous applicants need not apply.
About the role
We have a fantastic opportunity for a Pharmacovigilance (PV) Administrator to join the Oncology Clinical Trials Office (OCTO) working closely with the PV Manager to maintain appropriate safety reporting systems for OCTO trials. OCTO is the Oncology division of OCTRU, a UKCRC Registered Trials Unit.
The Pharmacovigilance Administrator will carry out varied work with the Pharmacovigilance Manager and with the individual trial management teams to provide technical expertise and administrative function, this includes:
• Logging and reviewing safety reports (Serious Adverse Events (SAEs)) from clinical trials and ensuring that the information is complete.
• Entering the data from the reports into the SAE database(s).
• Assessing expectedness for Serious Adverse Reactions, using approved Reference Safety Information.
• Generating concise, accurate and well-written case report narratives for SUSARs.
• Working with study sites to obtain timely and accurate follow-up information for each case.
• Supporting the PV manager with the writing of regulatory and committee reports.
The post is based in the Oncology Clinical Trials Office (OCTO), Churchill Hospital, Oxford, OX3 7LE and is fixed-term for two years in the first instance.
The post is full-time but part-time hours (minimum 0.8 FTE worked over no fewer than 4 days per week) will be considered. Any preference to work less than full-time should be indicated in your application.
You will be educated to BSc level (or equivalent) in a biomedical or a related sciences subject. You will be able to demonstrate a working knowledge of UK clinical research structures, regulatory and ethical systems. You will also have experience in working on clinical trials and an interest in working in pharmacovigilance in oncology. You will be able to demonstrate strong communicational skills and have excellent attention to detail. Ability to travel in the UK and further afield on limited occasions may be required.
You will be required to upload a CV and supporting statement (cover letter) and the names and contact details of two referees as part of your online application. Important: applicants who do not provide both a CV and a supporting statement, outlining why you are interested and how you meet the selection criteria for the role, will be rejected.
Only applications received by 12 noon on Tuesday 04 January 2022 can be considered.
Interviews are expected to take place during w/c 17 January 2022.
Committed to equality and valuing diversity
Contact Person :
Vacancy ID :
Contact Phone :
Closing Date & Time :
Contact Email :
Click on the link(s) below to view documentsFilesize
Pharmacovigilance (PV) Administrator Job description