FSP Associate Manager, Safety Data & Systems
Core
Lead deliverables for Global Patient Safety (GPS) Safety Data Management and Safety System Maintenance, providing high-quality data outputs for Safety Signal Management, Risk Management, and Safety Evidence generation.
Role type
Associate Manager, Safety Data & Systems (Pharmacovigilance)
Builds
Reliable and compliant drug safety case processing, safety reports, analytics, and system workflows
Domain
Life Sciences / Pharmacovigilance / Regulatory Compliance
Required skills
Safety database systems (Argus, ArisG), SQL, Excel, MedDRA dictionary, aggregate safety reports (DSUR, PSUR), global regulatory requirements (FDA, EMA, PMDA, ICH), system validation and testing, workflow management, data visualization
Preferred skills
Business Intelligence platforms, safety signal detection tools, E2B gateway
Technologies
Oracle Argus Safety, SQL, Excel, MedDRA, E2B gateway, BI platforms
Responsibilities
Manage and monitor GPS mailboxes including unblinded data; Serve as key technical resource for Oracle Argus Safety configuration, maintenance, and administration; Support day-to-day operation and troubleshooting of Argus Safety application; Generate, validate, and customize safety reports and analytics; Collaborate with pharmacovigilance, clinical, and regulatory teams to ensure alignment with global regulatory standards; Participate in change management processes for system workflows and integrations; Contribute to audit readiness activities; Develop procedural documents including Safety Management Plans and SOPs.
Seniority
Manager, hands-on IC