Safety Operations Manager, Global Patient Safety

argenx

. Oversee operational delivery and staff within Global Patient Safety Operations in accordance with GPS vision, strategy, and regulatory requirements .

Posted 10/2/2026full-timeRemote • Belgium, Switzerland, United StatesSeniorLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates advanced knowledge of pharmacovigilance processes and global regulations, with a strong background in post-marketing safety and experience in managing safety database systems. Proven ability to lead operational delivery, develop processes, and collaborate effectively with internal and external stakeholders.

Highest-signal resume keywords

Advanced Knowledge Of Pharmacovigilance ProcessesExperience In Global Pharmacovigilance/Drug SafetyProficiency With Safety Database SystemsAdvanced Written And Spoken EnglishBachelor’s/Master’s Degree In Healthcare Or Life Sciences

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Medical TerminologyPost-Marketing PharmacovigilanceGlobal Reporting RequirementsSafety Database SystemsMedDRA CodingWorkflow ManagementQuality Metrics EvaluationRegulatory ComplianceCase ProcessingAggregate Reporting

Soft Skills

CommunicationCollaborationProblem-SolvingLeadershipVendor Management

Tools & Technologies

ArgusMicrosoft OfficeExcelPowerPointVisio

Industry Keywords

Pharmacovigilance AgreementsSafety Data Exchange AgreementsHealth Authority InspectionsGlobal RegulationsEU And US Requirements

About the role

Key responsibilities & impact

Oversee operational delivery and staff within Global Patient Safety Operations in accordance with GPS vision, strategy, and regulatory requirements
Guide internal functions and external vendors to support seamless GPS Operations
Oversee and coordinate safety vendor and GPS teams for case triage and processing, expedited reporting, and aggregate reporting
Coordinate with and support GPS GSL team deliverables related to case processing
Collaborate with clinical, medical, regulatory, and other internal teams, as well as healthcare professionals, consumers, and contracted resources
Communicate with argenx, business partners, and distributors regarding Pharmacovigilance Agreements and Safety Data Exchange Agreements
Oversee assignment of Safety Specialist tasks and timely monitoring of GPS communications
Identify issues and improvement opportunities and escalate appropriately
Develop new processes and procedures and lead their implementation
Perform activities in compliance with argenx Controlled Procedures and applicable global and local regulations
Perform other tasks assigned by the line manager or Head of GPS

Requirements

What you’ll need

Advanced knowledge of medical terminology, pharmacovigilance processes, and relevant global regulations, including EU, US, and Japan requirements
Strong background/experience in post-marketing pharmacovigilance and global reporting requirements
Proficiency with safety database systems, including Argus, and MedDRA coding
Advanced computer skills, including Microsoft Office, Excel, PowerPoint, and Visio
Advanced written and spoken English
Experience participating in Health Authority inspections is advantageous
Bachelor’s/Master’s degree or local equivalent in nursing, healthcare, life sciences, or a relevant field
Minimum of 5 years of relevant experience in Safety, Clinical Research, or Pharmacovigilance
At least 7 years of relevant experience in global pharmacovigilance/drug safety in the EU and US
Equivalent and adequate combination of education and experience
Advanced expertise in global EU/US pharmacovigilance requirements and practices
Advanced experience with safety database systems, preferably ARGUS, including workflow management
Proven experience interacting with third-party vendors
Proven experience identifying quality issues and evaluating quality metrics
Must be located in Belgium, Switzerland, or the US (EST time zone)

Benefits

Comp & perks

Short-term incentives program
Long-term incentives program
Inclusive environment
Equal consideration for employment without discrimination