Regional PV Director: Safety Strategy & Compliance

Argenx; United States; Remote; USD 192,000 - 264,000; Full time

Benefits offered by this job

Incentives program

Inclusive, diverse workplace

Job summary

argenx seeks a senior Pharmacovigilance professional to serve as the country/region expert, coordinating PV activities with the GM, regulatory affairs lead and medical director. You will ensure compliance with US and global PV standards, manage safety documentation, and support cross-functional teams in an international, fast-paced biotech environment.

You will oversee PV systems, contribute to regulatory responses, and participate in audits and governance committees to drive safety excellence

Qualifications

• Master’s degree in pharmacy, nursing, healthcare or other life-science or technical field; PharmD/MD a plus.
• At least 10-15 years in pharma/biotech with 8+ years in pharmacovigilance/drug safety.
• Knowledge of pharmacovigilance regulatory requirements and GVP guidance documents.
• US EST time zone location is required for consideration.

Responsibilities

• Act as main PV contact for external and internal partners in the country/region.
• Collaborate with quality, legal, marketing, and other teams.
• Establish and maintain country/region PV systems.
• Support harmonization of PV processes across regions.
• Support PV in innovation projects to improve regional efficiency.
• Promote compliance with pharmacovigilance obligations.
• Respond to local regulatory PV requests and FDA interactions as needed.
• Lead PVA preparation with cross-functional teams.
• Oversee documentation for outsourced activities and GPS audits.
• Lead PSMF data collection in the country/region.
• Review documents for non-interventional studies and data collection.

Skills

Presentation skills

Planning & organization

Written & verbal communication

Independent work in global environment

Safety/regulatory knowledge

English fluency

Education

Master’s degree in pharmacy, nursing, healthcare or life sciences

Tools

Microsoft Office

Job description

argenx seeks a senior Pharmacovigilance professional to serve as the country/region expert, coordinating PV activities with the GM, regulatory affairs lead and medical director. You will ensure compliance with US and global PV standards, manage safety documentation, and support cross-functional teams in an international, fast-paced biotech environment.

You will oversee PV systems, contribute to regulatory responses, and participate in audits and governance committees to drive safety excellence