Safety Systems Associate I , 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 groups 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 associate 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). • Participate in all data migration activities and documentation related to migration. • 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. • Respond to mailbox queries. • Monitor the mailbox for system failures to resolve in a timely manner. • 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. • At least 1 year of experience with drug safety systems such as Argus/ARISg/Veeva. Experience (Minimum Required): • Experience in systems operations support role. • Experience working on any validated document management systems. • Good working knowledge of Microsoft office tools. • System integration knowledge. 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 .