Director, Safety Data & Systems

argenx

Remote, United States
Base: $192,000.00 - $264,000.00 usd annually; bonu...
Fully remote
Advanced knowledge of pv regulatory requirements
Expert level excel skills required
Proficiency in argus safety database systems
argenx is seeking a Director of Safety Data & Systems to oversee Global Patient Safety operations, focusing on the management and maintenance of safety data and systems. This fully remote role requires extensive experience in pharmacovigilance and safety database administration, aiming to enhance the company's innovative approach in delivering treatments for autoimmune diseases

Job Summary

  • The Director will oversee the maintenance and updates of the global safety database for all argenx products and new programs while ensuring high-quality data provision for safety signal management.
  • This role requires advanced proficiency in safety database systems like Argus and the ability to collaborate with global functions and vendors to maintain regulatory compliance across Europe, US, and Japan.
  • Candidates must have at least 10 years of relevant experience in IT, Safety, or Pharmacovigilance with a minimum of 5 years specifically in safety database setup and maintenance.

Matching Summary

Match Score: 85

argenx is seeking a Director of Safety Data & Systems to oversee Global Patient Safety operations, focusing on the management and maintenance of safety data and systems. This fully remote role requires extensive experience in pharmacovigilance and safety database administration, aiming to enhance the company's innovative approach in delivering treatments for autoimmune diseases.

Salary

Base: $192,000.00 - $264,000.00 USD annually; Bonus/Equity: Eligible for short-term and long-term incentive programs; Benefits: Comprehensive package including retirement savings plans and health benefits

Skills & Requirements

Must-have

  • Advanced knowledge of PV regulatory requirements
  • Expert level Excel skills required
  • Proficiency in Argus Safety Database systems
  • Experience with E2B gateway and signal detection tools
  • Knowledge of MedDRA dictionary and workflow case processing
  • Robust understanding of quality management processes and KPIs

Nice-to-have

  • Experience with SQL is a plus
  • Proven ability to work independently with minimal oversight
  • Ability to assume Line Management responsibility
  • Fluent communication in written and spoken English

Key Requirements

  • Bachelor's degree in life sciences or IT
  • Minimum 10 years of relevant experience
  • At least 5 years in Safety database setup and maintenance
  • Advanced computer skills including PowerPoint and Visio

Work Rights

Not specified

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