Safety System Manager, Argus SME

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.

• 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.

• 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.
• Independently driving meetings and developing the IT system strategy, Compliance

management, periodic System Evaluation, reviewing Enterprise Architecture of the system.

• Support and educate end users and sponsors, if applicable.
• Collaborate with training team in development ofsafety 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).

• Actively participate in all data migration activities and documentation related to migration.
• Support with change management and training of the systems, as needed.
• Respond to mailbox queries.
• 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 them promptly.
• 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.
• Monitors staff projects quality, timelines, and budgets to foresee and correct issues and assure

project expectations are met.

• Help staff identify resource or scope of work changes.
• Effectively communicate the status of projects to line management and project managers.
• Manages discretionary expenses and spending within team to meet budget.
• Working closely with leads to ensure that staff resources are used efficiently, and the team is

well utilized.

• Managesresources within team: new hires, terminations, transfers, and contractors.
• Carry out line management responsibilities for assigned staff, including Performance

Management and Development activities, disciplinary procedures, and administrative activities.

• Helps encourage staff career growth and development.
• Provides system support and technical support to team members.
• Act as the lead overseeing technical planning for increasingly complex projects including global

and multiple study projects and electronic submissions.

• Representing Systems team at internal project team meetings, client meetings and audits.
• Contribute to ongoing improvement of programming processes, methodology and

documentation.

• Facilitate advanced technical expertise, share knowledge at department meetings.
• Keeps abreast of new Safety system practices, methods and tools, regulatory practices, and

industry trends to stimulate departmental growth.

• Responsible for taking care of Project management activities and working on Client

communications.

• Collaborating closely with the key stakeholders including follow-up on vendor deliverables and

service according to agreements.

• Carry out end to end release management cycle of the IT System.
• Responsible for the operation and maintenance of critical IT systems located and used in

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• Global Job Description Template v1 - 01September2023
• different departments.

• Managing stakeholder and vendor activities.
• And all other duties as needed or assigned.

Qualifications(Minimum Required)

• Life Science or IT/computing degree.
• Experience in systems operations support role.
• Experience working on any validated document management systems.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Good working knowledge of Microsoft office tools.
• System integration knowledge.
• Required Skills- Change Management, Customer Relationship Management (CRM), people

management, Vendor Management.

Experience (Minimum Required)

• 8+ years of experience with drug safety systems such as Argus/ARISg/Veeva.
• 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.

Learn more about our EEO & Accommodations request here .