Senior Regional PV Director

argenx; United States; On-site; USD 192,000 - 264,000; Full time

Job summary

argenx is seeking a senior Pharmacovigilance professional to serve as a scientific expert and PV resource for the US region. You will lead pharmacovigilance systems, ensure regulatory compliance, and collaborate across quality, legal, marketing, and medical teams to support product safety and lifecycle activities.

With 10–15 years in pharma/biotech and strong English communication, you will engage with FDA interactions and drive process harmonization across regions while contributing to GP and

Qualifications

• Master’s degree in pharmacy, nursing, healthcare or other life-science or technical field (PharmD or MD is a plus).
• At least 10-15 years of experience in the pharmaceutical/biotech industry or regulatory authorities with at least 8 years in pharmacovigilance/drug safety.
• Working knowledge of pharmacovigilance regulatory requirements and GVP guidance documents.
• Knowledge of the drug development process, GXP quality and compliance requirements.
• Candidates must be located in the EST time zone to be considered for this role.

Responsibilities

• Act as the main point of contact for pharmacovigilance and serve as a key partner to the general manager, regulatory affairs lead, and medical director in the assigned country/region.
• Closely collaborate with other functions including quality, legal, marketing, commercial, communications, as well as other teams as needed.
• Establish and maintain the applicable pharmacovigilance system specific to the country/region
• Support the Head of Regional PV in the harmonization of processes across the regions
• Support the Head of Regional PV in the management of innovation projects for increasing Regional Team efficiency.

Skills

Excellent presentation skills

Fluency in written and spoken English

Excellent planning and organizational

Ability to work independently and in a

Education

Master’s degree in pharmacy, nursing, healthcare or other life-science or technical field

Tools

Microsoft Office Suite

Job description

argenx is seeking a senior Pharmacovigilance professional to serve as a scientific expert and PV resource for the US region. You will lead pharmacovigilance systems, ensure regulatory compliance, and collaborate across quality, legal, marketing, and medical teams to support product safety and lifecycle activities.

With 10–15 years in pharma/biotech and strong English communication, you will engage with FDA interactions and drive process harmonization across regions while contributing to GP and