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 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).
• •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.
• •Manages resources 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
• •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):
• •10+ 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.

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