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 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 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.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.