Safety Operations Manager, Global Patient Safety
About The Position
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.
Requirements
- 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
- 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
Nice To Haves
- Experience of active participation in Health Authority inspections would be an advantage
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
Benefits
- This job is eligible to participate in our short-term and long-term incentives program.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
