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.
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