Safety Operations Manager, Global Patient Safety

argenx SE; Oost-Vlaanderen; On-site; EUR 90,000 - 150,000; Full time

Job summary

argenx is seeking a seasoned professional to oversee Global Patient Safety Operations, coordinating with vendors and GPS teams worldwide to ensure compliant, timely case processing and reporting. The role collaborates with clinical, medical and regulatory functions to deliver safety deliverables and manage PV agreements.

Ideal candidates bring 7+ years in global PV with ARGUS experience, strong English communication, and a track record of process improvement within regulated environments.

Qualifications

• Bachelor’s or Master’s degree in nursing, healthcare or life sciences
• Minimum 5 years in Safety/Clinical Research/Pharmacovigilance
• 7+ years in global pharmacovigilance/drug safety (EU/US)
• Advanced expertise of global PV requirements and practices
• Proven experience with safety database systems (ARGUS preferred) including workflow management
• Experience with interaction with 3rd party vendors
• Located in Belgium, Switzerland or US (EST time zone) to be considered for this role.

Responsibilities

• Oversees and coordinates with safety vendor and GPS teams regarding case triage and processing, expedited and aggregate reporting
• Coordinates with GPS GSL team in relations to case processing
• Collaborates with clinical, medical, regulatory teams and external parties regarding safety deliverables and processes
• Communicates safety deliverables within argenx and with distributors regarding PV Agreements / SDEA
• Oversees assignment of Safety Specialist tasks and timely monitoring of GPS communications
• Identifies issues and areas for improvement and escalates appropriately
• Leads development and implementation of new processes and procedures
• Performs activities in compliance with argenx procedures and global/local regulations

Skills

Pharmacovigilance expertise

Cross-functional collaboration

English communication

Risk identification and mitigation

Safety process improvement

Education

Bachelor’s or Master’s degree in nursing, healthcare or life sciences

7+ years in global PV/drug safety

Tools

ARGUS proficiency

Microsoft Office (Excel, PowerPoint, Visio)

Job description

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.

PURPOSE OF THE FUNCTION

Oversees operational delivery and staff within Global Patient Safety (GPS) Operations, in accordance with the GPS vision, strategy and regulatory requirements. Interacts with and provides guidance to internal functions and external vendors as required for seamless GPS Operations.

REPORTING LINE

Director, Global Patient Safety Operations

ROLES AND RESPONSIBILITIES

• Oversees and coordinates with safety vendor and GPS teams regarding case triage and processing, expedited and aggregate reporting
• Coordinates with and supports deliverables with GPS GSL team in relations to case processing
• Collaborates with other internal teams (including clinical, medical, or regulatory) and external parties (including HCPs, consumers, or contracted resources) regarding safety related deliverables and processes
• Communicates within argenx and with business partners or distributors regarding deliverables related to PV Agreements (PVA) / Safety Data Exchange Agreements (SDEA).
• Oversees assignment of Safety Specialist tasks, i.e. regarding timely monitoring of GPS communication
• Proactively identifies issues and areas for improvement and escalates appropriately
• Proactively engages in the development of new processes and procedures and leads implementation of those
• Performs all activities in compliance with applicable argenx Controlled Procedures and with global and local regulations as applicable.
• Performs other tasks as assigned by line manager or Head of GPS

SKILLS AND COMPETENCIES

• Advanced knowledge of medical terminology, pharmacovigilance processes and relevant regulations, including global requirements (e.g. EU, US, Japan)
• A strong background/experience of post-marketing pharmacovigilance and knowledge of global reporting requirements
• Proficiency with safety database systems (i.e. Argus) and MedDRA coding
• Advanced computer skills, including proficiency with Microsoft Office including Excel, Power Point, Visio
• Communicates complex issues in an understandable, effective and relevant manner
• Manages and prioritizes a variety of tasks for self and team to meet required deadlines
• Makes operational decisions with limited supervision and has a good understanding of the overall impact and potential risk
• Identifies complex problems, raises issues and proposes solutions constructively
• Proven ability to communicate effectively and collaborate successfully across functions and with vendors
• Advanced communication in written and spoken English required
• Experience of active participation in Health Authority inspections would be an advantage

EDUCATION, EXPERIENCE AND QUALIFICATIONS

• Bachelor’s /Master’s degree (or local equivalent) in nursing, healthcare or other life-science or relevant field
• Minimum of 5 years of relevant experience in Safety / Clinical Research / Pharmacovigilance
• At least 7 years of relevant experience in global pharmacovigilance/drug safety (EU&US)
• Equivalent and adequate combination of education and experience
• Advanced expertise of global (EU/US) pharmacovigilance requirements and practices
• Advanced experience with safety database systems (ARGUS preferred) including workflow management
• Proven experience in interaction with 3rd party vendors
• Proven experience with the identification of quality issues and evaluation of quality metrics
• Candidates must be located in Belgium, Switzerland or US (EST time zone) to be considered for this role.

At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.

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argenx is a global immunology company dedicated to improving the lives of people suffering from severe autoimmune diseases. Through our rich pipeline of first-in-class therapies, led by VYVGART®, we are accelerating progress toward our bold 2030 vision: to reach 50,000 patients and transform the landscape of autoimmune treatment. Our innovation mission combines with meaningful work and endless opportunities for growth to create once-in-a-career experiences. argonauts work in locations around the globe including Belgium, Boston, Japan and Amsterdam. There's more to discover at argenx, where our passion inspires bold possibility.