Safety Systems Specialist II, PSS

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. Summary of Responsibilities: - PV systems expert 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. - Evaluate proposed project ideas /software changes through technical impact analysis and estimated business value to contribute to decision-making. - Develop and document standard and ad hoc reports from the safety systems. - Support and educate end users and sponsors, if applicable. - Collaborate with training team in development of safety system specific training Module. - Initiate discussions with business stakeholders to understand business requirements, document user requirements and ensure requirements are delivered on time and in collaboration with Tech partner. - Provide overall guidance and strategize use of standard safety systems front-end reporting including use of advanced conditions and Standard MedDRA Queries (SMQ). - 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. - Expertise in Ticket management, issue resolution and escalating system issues where applicable. - Respond to mailbox queries. - Vendor management. - Train team members on technical and functional aspects. - Completing work assignments to the highest quality standards, adhering to relevant SOPs, and keeping up to date with knowledge of current PV regulations. - Making updates to Departmental Standard Operating Procedures, Working Practices and Guidelines. - Monitor the mailbox for system failures to resolve in a timely manner. - Subject matter expert, looking for ways to improve compliance, quality, and efficiency. - Perform User Acceptance Testing and complete required documentation. - Lead critical team projects, responsible for managing team’s workload. - 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. - 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. Experience (Minimum Required): - Experience in systems operations support role. - Experience working on any validated document management systems. - At least 4 years of experience with drug safety systems such as Argus/ARISg/Veeva. - Good working knowledge of Microsoft office tools. - System integration knowledge. Preferred Qualifications Include: - 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.