Visit acad.jobs with all Jobs for Academics!
                    
Position: Pharmacovigilance Manager
Institution: University College London
Department: Cancer Institute
Location: London, United Kingdom
Duties: The Pharmacovigilance Manager will be a member of the Cancer Trials Centre (CTC) Regulatory team a group which supports and advises CTC trial staff to ensure compliance with applicable guidelines and regulations. The main purpose of the post is to oversee PV activities within the CTC, ensuring patient safety and compliance with regulatory requirements are maintained at all times. The post is office-based but will require occasional travel within the UK to attend meetings, training and conferences. The PV Manager has specific and overall responsibility for maintaining oversight of safety reporting systems for the CTC and ensuring that trials comply with all relevant legislation and guidelines pertaining to pharmacovigilance
Requirements: The post would suit a proactive, enthusiastic individual with an excellent understanding of clinical trial conduct, and regulatory requirements, a passion for pharmacovigilance and an interest in working in a busy and successful academic Clinical Trials Unit. The postholder will have a degree, or equivalent, in the life sciences area and substantial experience as a drug safety/pharmacovigilance professional, including experience of working within the clinical trial setting. He/she will be able to demonstrate an excellent understanding of current regulations and guidance governing clinical trials and pharmacovigilance
   
Text: Pharmacovigilance Manager, - Ref:1785703 Click here to go back to search results Apply Now UCL Department / Division Cancer Institute Specific unit / Sub department CR-UK & UCL Cancer Trials Centre Location of position London Grade 8 Hours Full Time Salary (inclusive of London allowance) ?43,884 - ?51,769 per annum Duties and Responsibilities The Cancer Research UK & UCL Cancer Trials Centre (CTC) http://www.ctc.ucl.ac.uk/ is part of the Cancer Institute at University College London. The CTC is a UK Clinical Research Collaboration (UKCRC) Registered Clinical Trials Unit (CTU) and undertakes the development and conduct of clinical trials to evaluate new approaches to the treatment of cancer. CTC staff collaborate with clinicians and research staff in the UK and abroad. Trials undertaken by the CTC are predominantly multicentre phase II and III trials using survival, tumour response or quality of life as endpoints. There is an expanding portfolio of phase I, II and feasibility studies, including first-in-man trials, some with biological endpoints, and most with a translational research component. The majority of CTC trials involve investigational medicinal products and therefore fall within the remit of European Union Clinical Trial Directive (EUCTD) and associated guidelines and regulations. The CTC also conducts trials of methods of screening for cancers and trials of non-drug therapies, such as surgery and radiotherapy. All trials are also governed by other UK legislation and guidance, including the UK Policy Framework for Health and Social Care Research, and data protection legislation. UCL acts as Sponsor for the majority of CTC trials, but delegates many sponsorship duties to the CTC through a Memorandum of Understanding. The Pharmacovigilance Manager will be a member of the CTC Regulatory team a group which supports and advises CTC trial staff to ensure compliance with applicable guidelines and regulations. The team is led by the Regulatory Manager and, in addition to the PV Manager and a PV Officer, includes a Regulatory Manager (Quality), Monitoring Coordinator, and Trial Monitors. The main purpose of the Pharmacovigilance Manager (PV) post is to oversee PV activities within the CTC, ensuring patient safety and compliance with regulatory requirements are maintained at all times. The post is office-based but will require occasional travel within the UK to attend meetings, training and conferences. The PV Manager has specific and overall responsibility for maintaining oversight of safety reporting systems for the CTC and ensuring that trials comply with all relevant legislation and guidelines pertaining to pharmacovigilance. The PV Manager works closely with trial teams in undertaking the duties of the role. The post is funded for 1 year in the first instance. Key Requirements The post would suit a proactive, enthusiastic individual with an excellent understanding of clinical trial conduct, and regulatory requirements, a passion for pharmacovigilance and an interest in working in a busy and successful academic Clinical Trials Unit. The postholder will have a degree, or equivalent, in the life sciences area and substantial experience as a drug safety/pharmacovigilance professional, including experience of working within the clinical trial setting. He/she will be able to demonstrate an excellent understanding of current regulations and guidance governing clinical trials and pharmacovigilance. He/she will also have experience of report writing in lay and scientific language (including involvement in the preparation/review of Development Safety Update Reports or Periodic Safety Update Reports) and familiarity with Standard Operating Procedures (SOPs) and SOP writing. Experience with audit and/or statutory inspections and a knowledge of cancer and pharmacology would be desirable. Further Details A job description and person specification can be accessed at the bottom of this page. To apply for the vacancy please click on the ?Apply Now? button below. If you have any queries regarding the application process please contact Louise Rusha, l.rusha@ucl.ac.uk . For informal enquiries about the vacancy please contact Nicky Gower (Regulatory Manager), n.gower@ucl.ac.uk , 020 7679 9863. We particularly welcome applications from black and minority ethnic candidates as they are under-represented within UCL at this level. Closing Date 3 Feb 2019 Latest time for the submission of applications 23:59 Interview date Week beginning 11 February 2019 Our department holds an Athena SWAN Silver award, in recognition of our commitment and demonstrable impact in advancing gender equality. This appointment is subject to UCL Terms and Conditions of Service for Research and Support Staff. Please use these links to find out more about UCL working life including the benefits we offer and UCL Terms and Conditions related to this job. Job description and person spec Apply Now
Please click here, if the Job didn't load correctly.







Please wait. You are being redirected to the Job in 3 seconds.