Safety Systems Associate 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 pgroups 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.
• 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.
• Support in Ticket management, issue resolution and escalating system issues where applicable.
• 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.
• Monitor the mailbox for system failures to resolve in a timely manner.
• Train team members on technical and functional aspects.
• Respond to mailbox queries.
• 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.
• Experience in systems operations support role.
• Experience working on any validated document management systems.
• At least 2 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):

• 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.

Preferred Qualifications Include:

• Life Science or IT/computing degree.
• 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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