Previously Senior Director, Drug Safety & Public Health, Gilead Sciences
Karen was responsible for all of the compliance metrics, standard operating procedures, review and interpretation of regulations, inspections, audits and all affiliate support work at Gilead Sciences.
Gilead Sciences was founded in 1987 and develops therapies for HIV/AIDS, liver diseases, haematology and oncology, inflammatory and respiratory diseases, and cardiovascular conditions. The organisation has experts working in many different disciplines with a focus to create products that will help patients. Gilead Sciences has bases in North and South America, Asia, Africa, Australia and 19 countries in Europe, with their International headquarters in the UK.
Karen’s team worked globally. They maintain the pharmacovigilance master file for Europe and prepare and administrate all of the pharmacovigilance and outsourced clinical trials licensing agreements for Gilead. The team also carry out all of the necessary affiliate support work and training with affiliates in local markets.
With such a global view and a wide remit within pharmacovigilance Karen sent a lot of her team members on DSRU pharmacovigilance and risk management training courses. Karen also attended as a course speaker from time to time to share her knowledge and expertise. The reason Karen chose DSRU over other training providers is the quality of the course content. She says ‘what you are getting is real and valid experience and not just a regurgitation of the regulations. Therefore you also get a good attendee base who participate and discuss the topics together, and share their own views and experience’. Karen says that is very different to other training providers who are not operating in the pharmacovigilance space. ‘DSRU are constantly scrutinising and changing and updating the content they present, and their speakers and presenters are actively engaged in pharmacovigilance work’.
Another reason why Karen sent her staff to DSRU is the level of participation they are offered. She says that the DSRU actively encourage people to say what they want to know in an open training forum. There are many experts attending the courses and conferences and questions can also be opened up to the floor as well as to the presenters and speakers. This is a unique opportunity to discuss topics and views across a spectrum of knowledgeable practitioners and regulators. Karen says that even as a lecturer she picks up new views and information each time. Over the past few years the DSRU courses have become more and more interactive and Karen says ‘students love it’.
Karen loved the diversity of her role at Gilead and built a very strong and knowledgeable team.