FSP Associate Manager, Safety Data & Systems

Location: Remote, North Carolina, USA

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

1 GENERAL INFORMATIONName of Role: Associate Manager, Safety Data & Systems, GPS OperationsFunction: Global Patient Safety (GPS)

2 PURPOSE OF THE FUNCTION

• Lead deliverables for GPS Safety Data Management and Safety System Maintenance activities
• Provide high quality data outputs for Safety Signal Management, Risk Management and Safety Evidence generation
• Collaborate and co-create with client functions and applicable vendors as required for seamless GPS Safety Data and Systems operations

3 REPORTING LINE

Sr. Director Safety Data and Systems, GPS Operations or designee

4 ROLES AND RESPONSIBILITIES

• Manages and monitors applicable GPS mailboxes including unblinded data
• Serve as the key technical resource for the configuration, maintenance, and administration of the Oracle Argus Safety system.
• Support day-to-day operation and troubleshooting of Argus Safety application to ensure reliable and compliant drug safety case processing.
• Assist in system validation, testing, and deployment of Argus Safety system updates, workflows, and business rules.
• Generate, validate, and customize safety reports and analytics using Argus reporting tools and associated business intelligence platforms.
• Collaborate closely with the pharmacovigilance, clinical, and regulatory teams to ensure safety data management aligns with global regulatory standards (FDA, EMA, PMDA, ICH).
• Participate in change management processes to enhance Argus Safety system workflows and system integrations.
• Contribute to audit readiness activities, including system inspections, validation reports, and compliance documentation.
• Collaborates with internal systems team, BIS and Safety vendor on issues related to Safety database configurations
• Performs the generation and quality control of aggregate reports and line listings
• Initiates and contributes to the development of procedural documents including but not limited to Safety Management Plans, SOPs, work instructions, job aides, forms, or templates
• Collaborates and co-creates with applicable client functions (e.g. Medical Information, Data Management, Business Information Systems, Quantitative Science) in regards to pharmacovigilance technical aspects, setup and operation
• Keeps up-to-date on applicable regulatory and PV tech guidelines and shares within GPS and client as applicable.
• Participates in training related to safety data management
• Proactively reviews processes and tools and provides suggestions for improvement and better efficiencies
• Complete additional task and projects as assigned by line manager or Head of GPS Operations / designee.

5 SKILLS AND COMPETENCIES

• Good knowledge of relevant pharmacovigilance regulatory requirements and guidance documents (including Europe, US, Japan)
• Adequate computer skills in all current office applications
• Proficiency with Excel is required, experience with SQL is a plus
• Proficiency in Safety Database systems (e.g. Argus) and knowledge of other technical systems applicable to Safety /Pharmacovigilance (e.g. E2B gateway, safety signal detection tools and systems).
• Proficiency in electronic systems commonly used for Safety / PV, like for data visualization and analysis, dashboards
• Robust understanding of the end to end process of clinical and post-marketing safety event collection and reporting including of workflow based case processing and MedDRA dictionary
• Solid understanding of the development and submission of aggregate safety reports (e.g. DSUR, PSUR)
• Solid understanding of the quality management processes, metrics and KPIs
• Ability to communicate effectively and collaborate successfully across functions and with vendors
• Fluent communication in written and spoken English required
• 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

6 EDUCATION, EXPERIENCE AND QUALIFICATIONS

• At least Bachelors’ degree (or country equivalent) in life sciences / Information technology or other relevant field required
• Solid knowledge of global (EU/US/Asia Pac) pharmacovigilance requirements and practices required
• Minimum of 7 years of relevant experience in IT / Safety / Clinical Research / Pharmacovigilance overall with at least 3 years of proven experience with safety database systems (e.g. ARGUS or ArisG) including workflow management
• Equivalent and adequate combination of education and experience or proven practical expertise in all of the required skills undefined