Senior Director, Vigilance (FDA Compliance)

Location: Lake Zurich, Illinois, United States. Priority is given to candidates near the U.S. headquarters who can work a weekly hybrid schedule of 3 days onsite and 2 days remotely. Candidates outside the area may work remotely with periodic travel.

Salary: $260,000–$280,000 per year, plus eligibility for a 22% annual bonus and a medium-term incentive plan.

Company

hirify.global develops and provides pharmaceutical, nutrition, IV therapy, and biosimilar products.

What you will do

• Set annual objectives and lead the strategic direction of the U.S. Vigilance function in alignment with global pharmacovigilance priorities.
• Oversee adverse drug experience activities, case reports, periodic FDA submissions, and the local pharmacovigilance system.
• Develop continuous quality plans, monitor KPIs, and maintain readiness for FDA inspections and audits.
• Direct literature reviews, clinical risk assessments, health hazard evaluations, signal management, and pharmacovigilance agreements.
• Partner with Regulatory Affairs and Quality Assurance on labeling changes, recalls, product quality issues, and safety decisions.
• Build and mentor a high-performing team, manage departmental budgets, and represent U.S. regulatory perspectives in global committees.

Requirements

• Medical or clinical professional degree required, such as PharmD, Pharmacy, or MD.
• 12+ years of pharmaceutical industry experience in drug safety or pharmacovigilance, including 7+ years of management experience.
• Thorough understanding of FDA regulations and guidelines related to post-marketed drug safety and compliance.
• FDA pharmacovigilance audit experience required.
• Ability to interpret federal regulations and assess medically complex adverse drug events for potential product quality issues.
• Intermediate Microsoft Office proficiency and expertise with pharmacovigilance and safety databases and reporting systems.

Nice to have

• 5+ years of hospital clinical experience.

Culture & Benefits

• Comprehensive medical, prescription drug, dental, and vision coverage.
• 401(k) plan with company contributions, paid vacation, holidays, and personal days.
• Life insurance, disability coverage, employee assistance, and wellness programs.
• Leadership role with opportunities to influence global pharmacovigilance standards and regulatory strategy.