Global Vigilance & FDA Compliance Director

Fresenius Kabi; Lake Zurich (IL); Ibrido; USD 260.000 - 280.000; Tempo pieno

Vantaggi offerti da questo lavoro

401(k) contributions

Paid vacation

Holiday and personal days

Employee assistance program

Health benefits (medical, prescription

Dental and vision coverage

Descrizione del lavoro

Fresenius Kabi USA in Lake Zurich, IL seeks a Senior Director of Vigilance and FDA Compliance to lead the U.S. pharmacovigilance and FDA regulatory program.

You will guide executive strategy, oversee adverse event activities, and ensure compliance with FDA regulations across multiple product lines. The role reports to the SVP of Regulatory Affairs for Pharma and Nutrition, manages a senior team, and will drive operational excellence, regulatory readiness, and cross-functional collaboration.

Competenze

• 12+ years in the pharmaceutical industry in a drug safety or pharmacovigilance role.
• 7+ years of management experience.
• 5+ years hospital clinical experience preferred.
• FDA pharmacovigilance audit experience required.

Mansioni

• Define and lead annual departmental objectives aligned with US market needs and global strategies.
• Provide executive leadership as Head of US Vigilance and set strategic direction for PV policy compliance.
• Oversee adverse drug event activities, case reports, and FDA submissions.
• Develop and execute a continuous quality plan for FDA PV compliance and KPI monitoring.
• Lead literature reviews, risk assessments, and signal management activities.
• Mentor and develop a high-performing Vigilance team and manage budgets.

Conoscenze

Regulatory leadership

Pharmacovigilance

Team management

FDA regulations

Stakeholder communication

Formazione

PharmD

MD

Descrizione del lavoro

Fresenius Kabi USA in Lake Zurich, IL seeks a Senior Director of Vigilance and FDA Compliance to lead the U.S. pharmacovigilance and FDA regulatory program.

You will guide executive strategy, oversee adverse event activities, and ensure compliance with FDA regulations across multiple product lines. The role reports to the SVP of Regulatory Affairs for Pharma and Nutrition, manages a senior team, and will drive operational excellence, regulatory readiness, and cross-functional collaboration.