Lead Safety Systems Specialist

Overview

Lead Safety Systems Specialist responsible for the implementation, support, configuration and migration of safety (pharmacovigilance) systems, delivered to internal and external clients either as support to project groups or as a stand-alone service.

What you'll do

• Conduct project-specific configurations in safety systems.
• Maintain and document system configuration based on initial requirements and subsequent changes.
• Evaluate proposed project ideas and 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, if applicable.
• Collaborate with the training team in developing safety-system-specific training modules.
• Initiate discussions with business stakeholders to understand business requirements, document user requirements and ensure requirements are delivered on time in collaboration with tech partners.
• Provide overall guidance and strategize use of standard safety systems front-end reporting, including advanced conditions and Standard MedDRA Queries (SMQ).
• Conduct routine and ad hoc data extraction (e.g., PSURs, DSURs, 6-monthly listings).
• Actively participate in all data migration activities and related documentation.
• Support change management and training of the systems, as needed.
• Manage tickets, resolve issues and escalate system issues where applicable.
• Respond to mailbox queries and monitor the mailbox for system failures to resolve in a timely manner.
• Manage vendors.
• Train team members on technical and functional aspects.
• Complete work assignments to the highest quality standards, adhere to relevant SOPs, and keep up to date with current PV regulations.
• Make updates to departmental Standard Operating Procedures, Working Practices and Guidelines.
• Act as subject matter expert, looking for ways to improve compliance, quality and efficiency.
• Perform User Acceptance Testing and complete required documentation.
• Lead critical team projects and manage the team's workload.
• Perform all other duties as needed or assigned.

What you'll need

• Life Science or IT/computing degree (Fortrea may consider relevant and equivalent experience in lieu of educational requirements).
• Good team player who offers 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.
• Ability to operate standard office equipment.
• Experience in a systems operations support role.
• Experience working on any validated document management systems.
• At least 4 years of experience with drug safety systems such as Argus, ARISg or Veeva.
• Good working knowledge of Microsoft Office tools.
• System integration knowledge.

Nice to have

• Clinical background working with clinical systems.
• Good understanding of the SQL programming language.
• Experience working with ticket support applications.

Details

• Work environment: office or remote.