Senior Safety Specialist

The Senior Safety Specialist will provide operational support to the Global Patient Safety (GPS) Operations, in accordance with the GPS vision, strategy and regulatory requirements. In this role you will interact with internal functions and external vendors as required for routine GPS operations.

Roles and Responsibilities:

• Regularly monitors and manages GPS mailboxes
• Communicates with safety vendor regarding individual case safety reports (ICSR) and aggregate reports / line listings
• Manages the reviews of ICSRs, listings, tables, and figures for completeness and quality as needed
• Manages (serious) adverse event reconciliation of databases and listings (post marketing and clinical trial sources) as required
• Collaborates with internal teams (including clinical, medical, or regulatory) and external parties (including HCPs, consumers, or contracted resources) to obtain safety information
• Participates in and takes minutes of meetings as required
• Supports the generation of aggregate safety reports
• Communicates with business partners or distributors regarding the receipt and transmission of safety information as per applicable safety data exchange agreements
• Attends GPS operational meetings and contributes as SME to topics discussed
• Proactively identifies issues and areas for improvement and escalates appropriately
• Contributes to the development of new processes and procedures
• Supports implementation of new processes and systems as required
• 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)
• Ability to communicate complex issues in an understandable, effective and relevant manner
• Ability to manage and prioritize a variety of tasks to meet required deadlines
• Ability to solve routine problems with limited supervision and to raise issues constructively
• Ability to deliver high quality documents, including work instructions, guidelines, forms and templates
• Takes ownership of assigned work and manages timelines for deliverables with minimal support
• Ability to make basic operational decisions with an understanding of the impact and potential risk
• Advanced computer skills, including proficiency with Microsoft Office
• Proficiency with safety database systems (i.e. Argus) and MedDRA coding

Education, Experience and Qualifications:

• Bachelor’s /Master’s degree (or local equivalent) in nursing, healthcare or other life-science or relevant field
• 3- 5 years of relevant experience in global pharmacovigilance/drug safety (EU&US)
• Equivalent and adequate combination of education and experience
• Solid experience with the end to end process of safety event collection and reporting
• Relevant experience with the development and submission of aggregate safety reports (e.g. DSUR, PSUR)
• Solid expertise of global (EU/US) pharmacovigilance requirements and practices
• Solid experience with safety database systems (e.g. ARGUS or ArisG) including workflow management
• Experience in interaction with 3rd party vendors would be a plus
• Experience with the generation and evaluation of quality metrics would be a plus

#LI-Remote

At argenx we strive to create a welcoming and inclusive environment. Here all applicants 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.

If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at hr.us@argenx.com. Only inquiries related to an accommodation request will receive a response.