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Hybrid Safety Systems, Assistant Manager bei Fortrea

Fortrea · Bangalore, IN, Vereinigte Staaten Von Amerika · Hybrid

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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. He/she will be 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 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.
    • At least 6 years of experience with drug safety systems such as Argus/ARISg/Veeva.
    • Good working knowledge of Microsoft office tools.
    • System integration knowledge.

    Experience (Minimum Required):

    • Experience in systems operations support role.
    • Experience working on any validated document management systems.
    • Clinical background working with clinical systems.
    • Good understanding of SQL programming language.

    Preferred Qualifications Include:

    • Life Science or IT/computing degree
    • Clinical background working with clinical systems.
    • Good understanding of SQL programming language.
    • 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.

    Physical Demands/Work environment:

    • Office Environment or remote.

    Learn more about our EEO & Accommodations request here.

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