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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