Associate Manager, Safety Data and Systems

argenx

Associate Manager maintaining Argus safety systems and pharmacovigilance data for argenx, a global immunology biotech. Supporting compliant safety reporting, validation, analytics, and system operations.

Posted 8/12/2026full-timeRemote • 🇺🇸 United StatesJuniorMid-Level💰 $88,000 - $121,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Safety Data Management and Pharmacovigilance, with proficiency in Argus Safety systems and compliance with global regulatory standards. Capable of generating high-quality safety reports and collaborating effectively with cross-functional teams.

Highest-signal resume keywords

Argus Safety System ProficiencyPharmacovigilance Regulatory KnowledgeSafety Data ManagementSQL ExperienceAggregate Safety Report Development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Safety Database SystemsData AnalysisWorkflow ManagementExcel ProficiencyE2B Gateways KnowledgeSafety Signal Detection ToolsMedDRA Dictionary UnderstandingQuality Management ProcessesAggregate Safety ReportsClinical Research Experience

Soft Skills

Independent WorkEffective PrioritizationTeam CollaborationCommunication SkillsProblem-Solving

Tools & Technologies

Argus Reporting ToolsBusiness Intelligence PlatformsElectronic Systems for Data VisualizationSafety Database Configuration ToolsOffice Applications

Industry Keywords

PharmacovigilanceClinical SafetyRegulatory ComplianceGlobal Safety StandardsSafety Evidence Generation

Tech Stack

Tools & technologies

OracleSQL

About the role

Key responsibilities & impact

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
Manage and monitor applicable GPS mailboxes, including unblinded data
Serve as the key technical resource for configuration, maintenance, and administration of the Oracle Argus Safety system
Support day-to-day operation and troubleshooting of the Argus Safety application
Assist in 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 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 system workflows and integrations
Contribute to audit readiness, 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
Develop procedural documents including Safety Management Plans, SOPs, work instructions, job aids, forms, and templates
Collaborate with argenx functions on pharmacovigilance technical aspects, setup, and operation
Keep current on regulatory and pharmacovigilance technology guidelines and share updates
Participate in safety data management training
Review processes and tools and suggest improvements and efficiencies
Complete additional tasks and projects assigned by the line manager or Head of GPS Operations

Requirements

What you’ll need

At least Bachelor's degree (or country equivalent) in life sciences, Information Technology, or another relevant field required
Solid knowledge of global EU, US, and Asia-Pacific pharmacovigilance requirements and practices
Minimum 7 years of relevant 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
Good knowledge of relevant pharmacovigilance regulatory requirements and guidance documents for Europe, the US, and Japan
Adequate computer skills in current office applications
Proficiency with Excel required
Experience with SQL is a plus
Proficiency in safety database systems such as Argus
Knowledge of technical systems applicable to safety/pharmacovigilance, including E2B gateways and safety signal detection tools
Proficiency in electronic systems used for safety/pharmacovigilance data visualization, analysis, and dashboards
Understanding of end-to-end clinical and post-marketing safety event collection and reporting, workflow-based case processing, and MedDRA dictionary
Understanding of development and submission of aggregate safety reports such as DSUR and PSUR
Understanding of quality management processes, metrics, and KPIs
Fluent 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
Equivalent and adequate combination of education and experience, or proven practical expertise in all required skills

Benefits

Comp & perks

Annual base salary range of $88,000.00 - $121,000.00 USD
Eligibility to participate in short-term incentive programs
Eligibility to participate in long-term incentive programs
Comprehensive benefits package
Retirement savings plans
Health benefits
Inclusive environment
Equal consideration for employment without discrimination