Jo Caley Email & Phone Number

Job title: Senior Team Leader, AE Info Management TeamKey Responsibilities : Manage and maintain the i3 safety database as an ‘application administrator’.o Participated in safety database patches, version upgrades, updates to dictionaries, data migrations.o Developed and executed performance qualification (PQ) scripts for safety database.o Ensure systems are E2B compliant (send and receive). Set up registration, testing and production status for EudraVigilance for all clients requiring this service.o Made electronic submissions and then developed a team to complete electronic submissions. Developed and maintained the safety database user guide. Developed and delivered safety database training for Pharmacovigilance staff. Developed custom safety reports through Business Objects and put together two suites of reports (one for general metric purposes and the other for signal detection and work up) Developed comprehensive International Drug Safety Training Program, which includeso technical database trainingo process trainingo regulatory training Provided training across international sites (Singapore, US and European sites). Lead development projects (both database and process perspectives)

Key Responsibilities :• Responsibility for the safety surveillance for three neuroscience post-marketed products worldwide (including one product as it launched worldwide) including -o signal evaluationo proactive surveillanceo ad hoc enquires from numerous sources (media/prescribing physicians/clinical teams), o preparing documents and producing recommendations for labelling reviewo answering regulatory enquireso the production of PSUR’s, IND reports, annual CT reports, risk benefit analyses (CIOMS V) and risk management plans (ICH E2E). • I have been an active member of cross-functional product teams, involved in decision-making, document review, and general management of the product. • Mentoring and coaching a team of scientists in surveillance activities.• Managed project teams of 12 people (including 5 physicians).• Developed my skills in Business Objects.• Was the key driver in initiating and leading a learning working group, resulting in monthly learning sessions (one of which I led myself) and a monthly journal club. • Identified areas in current processes, which required streamlining, set up working groups to identify possible solutions and ensure best practice and initiated piloting of the new processes.• Produced SOP’s and was responsible for periodic review to ensure they were up to date. • Informal team leader (team of 4) whilst restructuring was in progress (6 months).• Facilitated transatlantic training sessions (via teleconference) for the UK side.