Safety Operations Manager, Global Patient Safety

🔥 19 hours ago

🌐 Belgium, Switzerland, +1 more countries – Remote

🇧🇪 Belgium – Remote 🇨🇭 Switzerland – Remote 🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

⚙️ Operations

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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argenx

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2008

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

argenx is a biotechnology company committed to improving the lives of patients through immunology innovation. The company focuses on developing novel antibody-based therapies to treat severe autoimmune diseases. Using a collaborative approach with pioneering scientists and academic partners, argenx accelerates the discovery of therapeutic antibodies that target specific disease pathways. The company's proprietary products, such as efgartigimod, are aimed at treating diseases where IgG antibodies are pathogenic. Argenx emphasizes innovation, science of collaboration, and patient-centric approaches in its mission to deliver life-changing medical solutions.

📋 Description

• 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

• 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

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