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 Cathy Lisles

Cathy Lisles

Specialist in Pharmacovigilance and Safety

Overview

Hello, my name is Cathy and I am one of the Pharmacovigilence and Safety Specialists in the Centre for Trials Research in the School of Medicine at Cardiff University. My role is to help look after the safety aspects of clinical trials from trial set-up to archiving. Much of our time is spent in processing Serious Adverse Event (SAE) forms and ensuring that any Suspected, Unexpected Serious Adverse Events (SUSARs) are reported to the relevant national and international regulatory authorities according to the prescribed timelines.

Our team advises trial teams when setting up a trial as to which Reference Safety Information (RSI) to use and ensures that their safety documentation such as SAE forms is all in order ready to start the trial. Depending on the risk level of the trial when then may manage the processing of the SAEs, as well as provide regular reports for the trial team about the numbers of events to help them manage the trial.

Our office days are very busy as we try to ensure that we meet all of our processing deadlines. There is never a dull moment!

Biography

Current appointment: Oct 2017: Pharmacovigilance & Safety Specialist. CTR, College of Biomedical & Life Sciences

Previous appointment: March 2011 – October 2017: Data Manager – Centre for Trials Research·       

  • Worked as a researcher since 1991 on a wide range of social and health related topic areas.
  • Experienced in all aspects of data management; questionnaire design & distribution, creating metadata, designing & testing databases, monitoring & audit, pharmacovigilance, data entry, QC & query chasing, data coding & data cleaning
  • Experienced in use of SPSS, Access, Excel.
  • Regular teacher of SPSS. 

Publications

Teaching

Have taught various aspects of social research methods in past job roles including SPSS, which I continue to do, now and again.