Regional Pharmacovigilance Manager

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🌐 Belgium, Switzerland – Remote

🇧🇪 Belgium – Remote 🇨🇭 Switzerland – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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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

• Support oversight, harmonization and maintenance of regional pharmacovigilance activities, processes and deliverables • Contribute to pharmacovigilance systems for assigned countries or regions and align them with global GPS processes and standards • Monitor and communicate applicable pharmacovigilance legislation, regulatory expectations and safety requirements • Promote awareness of pharmacovigilance obligations and support compliance with local, regional and global requirements • Manage and maintain company and user profiles in regulatory authority databases and portals • Collaborate with Regulatory, Medical, Quality, Legal, Commercial and other teams • Develop relationships with cross-functional teams involved in adverse event reporting and safety data collection • Support oversight of individual case safety report processes and timely processing into the Global Safety Database • Support oversight and operational management of pharmacovigilance outsourcing vendors • Participate in GPS audit and inspection readiness, inspection support and management • Maintain knowledge of the company product portfolio, disease areas and marketed and developmental products • Contribute to continuous improvement and innovation initiatives for regional pharmacovigilance efficiency and process maturity • Perform other appropriate and requested tasks

🎯 Requirements

• Bachelor’s or Master’s degree in pharmacy, nursing, healthcare, life sciences or another relevant scientific field • Approximately 5 to 7 years of experience in the pharmaceutical or biotech industry, regulatory authorities or related environment • Solid experience in pharmacovigilance or drug safety • Working knowledge of pharmacovigilance regulatory requirements, GVP guidance documents and applicable GxP quality and compliance expectations • Experience preparing, reviewing or maintaining pharmacovigilance documents, procedures, work instructions or related controlled documents • High experience with individual case safety report processes and management of cases into a Global Safety Database • Experience overseeing or managing pharmacovigilance outsourcing vendors, including operational performance, quality follow-up and issue management • Experience in audit and inspection readiness, inspection support or participation in pharmacovigilance inspections preferred • Knowledge of regional pharmacovigilance operations, safety data collection and cross-functional PV processes preferred • Good planning and organizational skills • Good oral and written communication skills, including communicating complex issues to different audiences • Ability to collaborate effectively across multidisciplinary and global teams • Understanding of safety business processes, adverse event collection and pharmacovigilance systems • Problem-solving skills • Relevant computer skills, including proficiency with Microsoft Office Suite • Fluency in written and spoken English; other languages are an asset • Candidates must be based in Belgium or Switzerland

🏖️ Benefits

• Short-term and long-term incentives program eligibility • Locally applicable annual base salary hiring range shared during the recruitment process • Inclusive environment and equal consideration for employment without discrimination • Opportunities for growth