Anne Lucuta, PhD
Anne has 15+ years experience working in pharmacovigilance in both the Contract Research Organisation setting (IQVIA, formerly Quintiles) and in a global pharmaceutical company (Aspen Pharma). During her career, Anne has worked across a wide range of pharmacovigilance tasks including case processing, literature review and analysis, aggregate report drafting and schedule management, QC, signal detection, responding to regulatory authority queries, mentoring and training, regulatory intelligence, business development and client management. In her most recent position, Anne was responsible for managing the global aggregate reporting requirements for a large portfolio of 40+ medicinal products covering a wide range of therapeutic areas. Key skills include strong scientific writing, analysis and evaluation, faultless adherence to tight regulatory timelines and proficiency in managing several ongoing projects simultaneously. Anne is a graduate of University College Dublin having been awarded a PhD in Pharmacology. Prior to her pharmacovigilance positions she worked in clinical trial data management.
A Science graduate of Trinity College, Catherine has 10+ years experience in pharmacovigilance and medical affairs, both in the clinical (IQVIA, formerly Quintiles) and post-marketing setting (number of pharmaceutical companies). Her most recent position saw Catherine manage a large team of Scientists, across a vast portfolio of products (40+) in a global pharmacovigilance department. Catherine's areas of interest and expertise include signal management strategies, product review and harmonisation and process improvement/ trouble-shooting. Having worked on large global safety data harmonisation projects post merger, Catherine is familiar with the hurdles that face many companies when undertaking such projects. Catherine has also worked on global safety database migration projects as Reporting lead and is skilled in managing these types of project work streams to ensure that the outputs and analytics are optimal.