Lead Safety Systems Specialist

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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