Senior Director, Vigilance

• 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

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

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is atwill, meaning both the employee and 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 applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.