Safety Systems Associate II, PSS

Job description

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. Learn more about our EEO & Accommodations request here .