Data Manager Jobs

About The Position

Requirements

• At least a bachelor's degree or country equivalent in life sciences, information technology, or another relevant field.
• At least 7 years of relevant overall experience in IT, Safety, Clinical Research, or Pharmacovigilance.
• At least 3 years of proven experience with safety database systems such as Argus or ArisG, including workflow management.
• Solid knowledge of global pharmacovigilance requirements and practices, including EU, US, and Asia Pacific.
• Good knowledge of relevant pharmacovigilance regulatory requirements and guidance documents, including Europe, the US, and Japan.
• Adequate computer skills in current office applications.
• Proficiency with Excel.
• Proficiency in safety database systems such as Argus and knowledge of other safety and pharmacovigilance technical systems, such as E2B gateways and safety signal detection tools and systems.
• Proficiency in electronic systems commonly used in Safety/PV for data visualization, analysis, and dashboards.
• Robust understanding of end-to-end clinical and post-marketing safety event collection and reporting, including workflow-based case processing and the MedDRA dictionary.
• Solid understanding of the development and submission of aggregate safety reports, such as DSURs and PSURs.
• Solid understanding of quality management processes, metrics, and KPIs.
• Ability to communicate effectively and collaborate successfully across functions and with vendors.
• Fluent written and spoken English.
• Ability to work independently with minimal oversight and prioritize effectively.
• Ability to complete multiple complex deliverables within tight timelines.
• Ability to function effectively in a team environment.
• An adequate combination of education and experience, or proven practical expertise in the required skills, may be considered equivalent.

Nice To Haves

• Experience with SQL is a plus.

Responsibilities

• Manage and monitor applicable GPS mailboxes, including unblinded data.
• Serve as the key technical resource for Oracle Argus Safety configuration, maintenance, and administration.
• Support day-to-day operation and troubleshooting of the Argus Safety application to ensure reliable and compliant drug safety case processing.
• Assist with system validation, testing, and deployment of Argus Safety updates, workflows, and business rules.
• Generate, validate, and customize safety reports and analytics using Argus reporting tools and associated business intelligence platforms.
• Collaborate with pharmacovigilance, clinical, and regulatory teams to align safety data management with global regulatory standards.
• Participate in change management processes to enhance Argus Safety workflows and system integrations.
• Contribute to audit readiness, including system inspections, validation reports, and compliance documentation.
• Collaborate with internal systems teams, BIS, and safety vendors on safety database configuration issues.
• Generate and quality-control aggregate reports and line listings.
• Initiate and contribute to procedural documents, including Safety Management Plans, SOPs, work instructions, job aides, forms, and templates.
• Collaborate with client functions on pharmacovigilance technical aspects, setup, and operation.
• Stay current on applicable regulatory and PV technology guidelines and share relevant updates within GPS and with clients.
• Participate in safety data management training.
• Review processes and tools proactively and suggest improvements and efficiencies.
• Complete additional tasks and projects assigned by the line manager or Head of GPS Operations or designee.