About this role
Job Overview: Assist with the overall safety system implementation, support, configuration, and migration related activities. Responsible for providing this service to clients either as a support function to the client project pgroups or as stand- alone business. Responsible for providing all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. Expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual.
Summary of Responsibilities:
• PV systems team member responsible for leveraging a strong combination of business and technical knowledge. • Conduct project specific configurations in Safety systems. • Maintain and document system configuration based on initial requirements and any subsequent changes. • Develop and document standard and ad hoc reports from the safety systems. • Support and educate end users and sponsors, if applicable. • Conduct routine and ad hoc data extraction (i.e., PSURs, DSURs, 6-monthly listings). • Actively participate in all data migration activities and documentation related to migration. • Support with change management and training of the systems, as needed. • Support in Ticket management, issue resolution and escalating system issues where applicable. • Completing work assignments to the highest quality standards, adhering to relevant SOPs, and keeping up to date with knowledge of current PV regulations. • Perform User Acceptance Testing and complete required documentation. • Monitor the mailbox for system failures to resolve in a timely manner. • Train team members on technical and functional aspects. • Respond to mailbox queries. • Any other duties as assigned by management. • And all other duties as needed or assigned.
Qualifications (Minimum Required):
• Life Science or IT/computing degree. • Fortrea may consider relevant and equivalent experience in lieu of educational requirements. • Experience in systems operations support role. • Experience working on any validated document management systems. • At least 2 years of experience with drug safety systems such as Argus/ARISg/Veeva or equivalent. • Good working knowledge of Microsoft office tools. • System integration knowledge.
Experience (Minimum Required):
• Good Team player and offer peer support as needed. • Ability to set priorities and handle multiple tasks. • Attention to detail. • Good written and verbal communication skills. • Logical and spelling skills, preferably with an aptitude for handling and proof-reading numerical data. • Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial. • Ability to operate standard office equipment.
Preferred Qualifications Include:
• Life Science or IT/computing degree. • Clinical background working with clinical systems. • Good understanding of SQL programming language. • Experience working with ticket support applications.
Physical Demands/Work Environment:
• Office Environment or remote.
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