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:
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PV systems team member responsible for leveraging a strong combination of business and technical knowledge.
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Conduct project specific configurations in Safety systems.
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Maintain and document system configuration based on initial requirements and any subsequent changes.
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Develop and document standard and ad hoc reports from the safety systems.
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Support and educate end users and sponsors, if applicable.
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Collaborate with training team in development of safety system specific training module.
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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.
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Provide overall guidance and strategize use of standard safety systems front-end reporting including use of advanced conditions and Standard MedDRA Queries (SMQ).
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Conduct routine and ad hoc data extraction (i.e. PSURs, DSURs, 6-monthly listings).
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Actively participate in all data migration activities and documentation related to migration.
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Support with change management and training of the systems, as needed.
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Expertise in Ticket management, issue resolution and escalating system issues where applicable.
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Making updates to Departmental Standard Operating Procedures, Working Practices and Guidelines.
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Subject matter expert, looking for ways to improve compliance, quality and efficiency.
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Respond to mailbox queries.
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Completing work assignments to the highest quality standards, adhering to relevant SOPs and keeping up to date with knowledge of current PV regulations.
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Perform User Acceptance Testing and complete required documentation.
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Collaborate with training team in development of safety system specific training module.
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Provide overall guidance and strategize use of standard safety systems front-end reporting including use of advanced conditions and Standard MedDRA Queries (SMQ).
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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.
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Any other duties as assigned by management.
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And all other duties as needed or assigned.
Qualifications (Minimum Required):
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Life Science or IT/computing degree.
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Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
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At least 3 years of experience with drug safety systems such as Argus/ARISg/Veeva or equivalent.
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Good working knowledge of Microsoft office tools.
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System integration knowledge.
Experience (Minimum Required):
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Experience in systems operations support role.
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Experience working on any validated document management.
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Good keyboard skills, preferably with knowledge of MS office and Windows.
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Ability to operate standard office equipment.
Preferred Qualifications Include:
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Life Science or IT/computing degree
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Clinical background working with clinical systems.
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Good understanding of SQL programming language.
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Good Team player and offer peer support as needed.
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Ability to set priorities and handle multiple tasks.
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Attention to detail.
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Good written and verbal communication skills.
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Logical and spelling skills, preferably with an aptitude for handling and proof-reading numerical data.
Physical Demands/Work Environment:
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Office Environment or remote.
Legal
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