Job Overview:

• Assist with the overall Safety system implementation, support, configuration, and migration related activities.

• Responsible for providing 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 an appropriate quality of service in a safe and cost-effective manner.

• Provide supervision and day-to-day management of projects, ensuring quality, compliance, and timely delivery.

• Candidate will be expected to comply with the legal requirements of the Health & Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health & Safety Manual.

Summary of Responsibilities:

The statements below are intended to describe the job’s general nature and not to be an exhaustive list of all responsibilities, skills, and duties.

• PV systems expert responsible for leveraging a strong combination of business and technical knowledge.

• Conduct and oversee project specific configurations in safety systems.

• 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, as applicable.

• Collaborate with training team in development of safety system specific training modules.

• 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).

• Actively participate in and oversee data migration activities and documentation related to migration.

• Expertise in Ticket management, issue resolution and escalating system issues where applicable.

• Making updates to Departmental Standard Operating Procedures, Working Practices and Guidelines.

• Monitor the mailbox for system failures to resolve them promptly and manage vendor queries.

• Subject matter expert, looking for ways to improve compliance, quality, and efficiency.

• Perform and review User Acceptance Testing and complete required documentation.

• Lead critical team projects and are responsible for project deliverables within budget.

• Monitor staff project quality, timelines, and budgets to foresee and correct issues and assure project expectations are met.

• Effectively communicate the status of projects to line management and project managers.

• Carry out team development responsibilities including mentoring, and administrative activities.

• Support to new hires, onboarding, transfers, and contractors, in coordination with the reporting manager.

• Representing the Systems team at internal project team meetings, client meetings and audits.

• Contribute to the ongoing improvement of programming processes, methodology and documentation.

• Collaborate closely with key stakeholders including follow-up on vendor deliverables and service according to agreements.

• 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.

• Good working knowledge of Microsoft office tools.

• System integration knowledge.

• Required Skills – Project Management, Change Management, Customer Relationship Management (CRM), and Vendor Management.

Experience (Minimum Required): 

• 6+ years of experience in drug safety systems such as Argus/ARISg/Veeva, with a minimum of 2 years of project management experience.

• 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:

• Clinical background working with clinical systems – Good to have.

• Good understanding of SQL programming language – Good to have.

• Experience working with ticket support applications.

Physical Demands / Work Environment:

Office/Home-Based:

Work Environment:

o   Work is performed in an office environment with exposure to electrical office equipment.

o   Occasional drives to site locations with occasional travel both domestic and international.

Physical Requirements:

o   Frequently stationary for 6-8 hours per day.

o   Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

o   Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.

o   Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

o   Light to moderate lifting and carrying, or moving of objects, including luggage and laptop computer with a maximum lift of 15-20 lbs.

o   Regular and consistent attendance.

o   Varied hours may be required.

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