Senior Safety System Specialist

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 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. • 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. • Making updates to Departmental Standard Operating Procedures, Working Practices and Guidelines. • Subject matter expert, looking for ways to improve compliance, quality and efficiency. • Respond to mailbox queries. • 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. • Collaborate with training team in development of safety system specific training module. • Provide overall guidance and strategize use of standard safety systems front-end reporting including use of advanced conditions and Standard MedDRA Queries (SMQ). • 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. • 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. • At least 3 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): • Experience in systems operations support role. • Experience working on any validated document management. • Good keyboard skills, preferably with knowledge of MS office and Windows. • 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. • 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. Physical Demands/Work Environment: • Office Environment or remote. Learn more about our EEO & Accommodations request here.