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 Companys Health & Safety Manual.
Summary of Responsibilities:
The statements below are intended to describe the jobs 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 teams 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.

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