Director, Safety Data & Systems

argenx

Base: $192,000.00 - $264,000.00 usd; bonus/equity:...
Fully remote
Advanced knowledge of pharmacovigilance regulatory requirements
Expert level skill in excel usage required
Advanced proficiency in safety database systems like argus
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

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 collaborating with global functions and safety vendors to develop procedural documents, manage third-party oversight, and ensure compliance with regulatory requirements across Europe, US, and Japan.
  • Candidates must possess at least 10 years of relevant experience in IT, Safety, Clinical Research, or Pharmacovigilance with a minimum of 5 years specifically in Safety database setup and maintenance.

Matching 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.

Salary

Base: $192,000.00 - $264,000.00 USD; 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 pharmacovigilance regulatory requirements
  • Expert level skill in Excel usage required
  • Advanced proficiency in Safety Database systems like Argus
  • Minimum 10 years relevant experience in IT or Pharmacovigilance
  • At least 5 years proven experience in Safety database setup

Nice-to-have

  • Experience with SQL is a plus
  • Ability to assume Line Management responsibility
  • Proven ability to work independently with minimal oversight
  • Fluent communication in written and spoken English required
  • Knowledge of workflow based case processing and MedDRA dictionary

Key Requirements

  • Bachelor's degree in life sciences or Information Technology
  • 10+ years total experience in Safety/Pharmacovigilance
  • 5+ years experience in Safety database setup and maintenance
  • Advanced proficiency in Argus or similar safety database systems
  • Expert level Excel skills required

Work Rights

Not specified

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