Senior Director, Vigilance

Fresenius SE & Co. KGaA; Lake Zurich, Northern (IL, KY); Hybrid; USD 260,000 - 280,000; Full time

Benefits offered by this job

401(k) plan

Annual bonus

Medium-term incentive

Health benefits

Job summary

The Senior Director of Vigilance and FDA Compliance at Fresenius Kabi USA provides strategic leadership of the company’s global pharmacovigilance and FDA compliance program, ensuring adherence to U.S. regulatory requirements across Pharma, Nutrition, IV Therapy, and Biosimilar products.

Reporting to the SVP of Regulatory Affairs, this role leads a high-performing team and guides US strategy, while overseeing PV activities, FDA submissions, recalls, and regulatory readiness in a hybrid work model

Qualifications

• Medical or clinical degree (PharmD, Pharmacy, MD) required.
• 12+ years in pharmaceutical industry in drug safety or pharmacovigilance.
• 7+ years of management experience.
• FDA pharmacovigilance/regulatory compliance knowledge.
• Experience with FDA audits and compliant PV systems.
• Strong leadership, budgeting and cross-functional collaboration skills.
• Proficiency with Microsoft Office and PV safety databases.

Responsibilities

• Define and lead annual departmental objectives aligned with US market needs and global strategy.
• Provide executive leadership as Head of US Vigilance and set PV policy direction.
• Establish a compliant local PV system as NSO for US Market Unit.
• Oversee adverse drug experience activities, case reports, and FDA submissions.
• Develop and execute a continuous quality plan for FDA PV compliance.
• Direct literature reviews, risk assessments, safety signal management.
• Manage PV agreements with partners and ensure risk and compliance obligations.
• Represent US regulatory perspectives on global committees and drive standards.
• Guide labeling changes, recalls, and safety issue resolutions with Regulatory and QA.
• Build and mentor a high-performing Vigilance team; manage budgets and resources.

Job description

Job Summary

The Senior Director of Vigilance and FDA Compliance provides strategic leadership and oversight of the company’s global pharmacovigilance and FDA compliance program. This role ensures adherence to all U.S. regulatory requirements by overseeing robust systems for the intake, assessment, and reporting of adverse events across Pharma, Nutrition, IV Therapy, and Biosimilar products.

As a senior leader, the Senior Director serves as a key advisor to Global Vigilance and the Vigilance Competence Center, guiding U.S. FDA compliance strategy and enabling alignment of global pharmacovigilance practices. Reporting directly to the SVP of Regulatory Affairs for Pharma and Nutrition, this role manages a high-performing team that includes Senior Managers of Vigilance, as well as scientific, safety, data, and compliance professionals. The Senior Director is accountable for driving operational excellence, fostering regulatory readiness, mentoring senior leaders, and ensuring compliance strategies support both U.S. and global business objectives.

*Priority will be given to candidates who are in proximity to the Lake Zurich, IL U.S. headquarters and able to work a weekly hybrid schedule of 3 days onsite / 2 days remotely. If not near Lake Zurich, this position may be worked remotely with the expectation to travel periodically.

• Salary Range: $260,000-280,000.
• Position is eligible to participate in an annual bonus plan with a target of 22% of the base salary.
• Position is eligible to participate in our medium-term incentive plan.
• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities

• Define and lead annual departmental objectives, ensuring alignment with US market needs and global corporate strategies.
• Provide executive leadership as Head of US Vigilance, setting strategic direction, influencing global pharmacovigilance (PV) policies, and ensuring compliance with FDA regulations.
• Serve, upon nomination, as National Safety Officer (NSO) for the US Market Unit, accountable for establishing and maintaining a compliant local PV system, supported by the Deputy NSO.
• Act as the organization’s senior pharmacovigilance and FDA compliance expert, overseeing all Adverse Drug Experience activities, case reports, and periodic report submissions to the FDA.
• Develop, establish and execute a continuous quality plan for FDA PV compliance; monitor performance and KPIs across local and global systems.
• Oversee strategic direction of literature reviews, clinical risk assessments, health hazard evaluations, and signal management activities.
• Lead pharmacovigilance agreement oversight with business partners, ensuring risk management and compliance obligations are met.
• Serve as a member of global committees (Pharmacovigilance System Steering, Corporate Labeling, Global Signal Management), representing US regulatory perspectives and shaping corporate standards.
• Partner with Regulatory Affairs and Quality Assurance teams to guide labeling changes, recall decisions, and resolution of safety and product quality issues.
• Build, mentor, and inspire a high-performing Vigilance team; ensure continuous training, development, and regulatory expertise.
• Develop and manage departmental budgets, optimizing resources while driving innovation, compliance, and efficiency.
• Ensure effective communication and execution of policies, procedures, and SOPs across the Vigilance department and with cross-functional stakeholders.
• Represent Fresenius Kabi USA with professionalism and authority in global forums, regulatory interactions, and business partner engagements.
• Maintain a leadership presence as a subject matter expert, providing support to the Market Unit, Production Units, Business Units, R&D and Global Vigilance teams for PV and FDA compliance activities.
• Fulfill additional strategic responsibilities as required by executive leadership.

Job Requirements:

• Medical or clinical professional degree, such as PharmD, Pharmacy, MD, is required.
• 12+ years’ experience in the pharmaceutical industry in a drug safety or pharmacovigilance role, and 7+ years of management experience.
• 5+ years of hospital clinical experience preferred.
• Thorough understanding of FDA Regulations and Guidelines, especially as they pertain to Post Marketed Drug Safety, and compliance.
• FDA pharmacovigilance audit experience required.
• Ability to understand and interpret federal regulations and company operating procedures as they apply to medically complex adverse drug events and determine whether the events suggest a potential product quality issue
• Intermediate proficiency in Microsoft Office Suite and expertise with pharmacovigilance/safety databases and reporting systems

Additional Information

We offer an excellent salary and benefits package including medical, dental andvision coverage, as well as life insurance, disability, 401K with company contribution,and wellness program.

Please note that joining our team does not create a guaranteed or permanentemployment arrangement. All employment is at‑will, meaning both the employeeand Fresenius Kabi have the right to end the employment relationship at any time,in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicantswill receive consideration for employment without regard to race, color, religion, sex, national origin,citizenship, immigration status, disabilities, or protected veteran status.