Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description • 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