Advanced knowledge of pharmacovigilance regulations
Expert level excel skills required
Proficiency in argus safety database systems
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 implement procedural documents and maintain compliance with regulatory requirements across Europe, US, and Japan.
The position offers a competitive annual base salary range of $192,000.00 - $264,000.00 USD along with eligibility for short-term and long-term incentive programs.
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 regulations
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 processing
Robust understanding of quality management processes
Nice-to-have
Experience with SQL preferred
Ability to work independently with minimal oversight
Strong project management skills for complex deliverables
Fluent communication in written and spoken English
Key Requirements
Minimum 10 years relevant experience in IT/Safety/Clinical Research/Pharmacovigilance
At least 5 years proven experience in Safety database setup and maintenance
Bachelor's degree in life sciences or Information Technology
Proven ability to assume line management responsibility