James Kenny Email & Phone Number

Barcelona, Catalonia, Spain

● Global and local literature review.● Preparation of PSURs, ACOs, RMPs● Preparation and maintenance of Asphalion internal procedures● Preparation and maintenance of PSMF● Establish and maintain updated pharmacovigilance agreements. ● Perform PV trainings to other departments and/or third parties.● Keeping clients informed about local pharmacovigilance legislation and any changes regarding the requirements of the Regulatory Authorities.● Contribute to Audit and Inspection preparations.● Case processing and management in different databases like PcVmanager, SafetyEasy, Argus, eVeDrug and case reporting through EudraVigilance and MHRA portal.● Management and administration of databases: PcVmanager, SafetyEasy, Argus and eVeDrug ● Preparation of all the required documentation for a Database migration● Database validation, including the preparation of the validation plan, performance of the OQ and PQ and subsequent reports.

Dublin, County Dublin, Ireland

PgDip Pharmaceutical Business & Technology

Málaga, Andalusia, Spain

Dublin City, County Dublin, Ireland

Team Leader on regulatory projects which involved identifying project needs, tracking project timelines, implementing client requests and triaging day-to-day workload.Assess Lifecycle Safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, Provided training and mentoring of new staffPlayed a pivotal role in transitioning from paper based SUSAR reporting to a digital reporting system to Ethic Committees and Regulatory Authorities

Dublin, County Dublin, Ireland

• Assisted customers of the Business On Line business banking website with technical and banking queries, by phone and email• Worked as part of a team and coordinated to ensure an appropriate service level• Liaised with software development teams to report and troubleshoot defects in the system• Gathered and accurately documented customer information and requests in accordance with standard policies

Bachelor'S Degree, Molecular Medicine

Postgraduate Degree, Pharmaceutical Business And Technology