Senior Project Manager, Vigilance

Fresenius Kabi USA

Sr Project Manager responsible for managing Vigilance projects in the pharmaceutical industry. Overseeing drug safety processes and team collaboration while ensuring compliance with regulations in Lake Zurich, IL.

Posted 4/16/2026full-timeLake Zurich • Illinois • 🇺🇸 United StatesSenior💰 $155,000 - $185,000 per yearWebsite

About the role

Key responsibilities & impact

Lead and manage new initiatives whether initiated by a global function, or a local business contract, establishing project timelines and key goals, ensuring Vigilance participation on global and local due diligence evaluations.
Responsible for writing and/or review of applicable Standard Operating Procedures (SOPs).
Identify new procedures needed and changes to be made to established procedures to implement projects.
Ensure that all global and local procedures are in alignment.
Responsible for leading and managing all activities related to pharmacovigilance activities with Fresenius Kabi USA business partners, and third-party manufacturers (TPM), both locally and globally.
Manage communications with product business partners and establish pharmacovigilance and data exchange agreements.
Establish relationships and safety and data exchange agreements (SDEA) with business partners or TPMs, ensuring they meet all global and local regulations, policies and procedures.
Ensure execution and implementation of SDEA and provide oversight of all data exchange and reconciliation activities.
Drive new initiatives, establishing project timelines and key goals, ensuring Vigilance participation on global and local due diligence evaluations.
Lead a team of Drug Safety Scientists and Data Specialists in all aspects of adverse drug event processing and reporting, reconciliation activities, and other tasks/responsibilities as required.
Review and approve adverse event information entered into global complaint management workflow (gCMW).
Train and mentor staff regarding all established procedures and agreements.
Responsible for managing and facilitating the preparation, review, and submission of expedited, as well as non-expedited case reports in accordance with SOPs, as well as domestic and foreign regulatory requirements.
Serve as an Adverse Drug Event (ADE), PV expert, and MedDRA coding expert.

Requirements

What you’ll need

Bachelor’s degree required.
Medical/Clinical professional or advanced degree preferred (e.g., PharmD, RPh, RN, MS, or MBA).
8+ years of experience in the pharmaceutical industry in a drug safety or pharmacovigilance department required.
3+ years of management experience or experience leading successful teams required.
3+ years of hospital/clinical experience preferred.
Global experience preferred.
Experience with adverse drug event software is preferred.
Knowledgeable of the ARIS global database is a plus.
Understand FDA compliance, quality, risk, mitigation and planning, and management.
Ability to understand and interpret federal regulations and company operating procedures as they apply to medically complex adverse drug events.
Knowledge of PC systems and Microsoft Office Suite required.

Benefits

Comp & perks

Position is eligible to participate in an annual bonus plan with a target of 14% of the base salary.
Comprehensive benefits and programs for healthy lives and support when needed.
401(k) plan with company contributions.
Paid vacation, holiday and personal days.
Employee assistance program.
Health benefits to include medical, prescription drug, dental and vision coverage.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

pharmacovigilanceadverse drug event processingMedDRA codingSOP writingdata exchange agreementsregulatory compliancecase report submissiondata reconciliationproject managementdrug safety

Soft Skills

leadershipteam managementcommunicationmentoringrelationship buildingorganizational skillsproblem-solvingtraining

Certifications

Bachelor's degreePharmDRPhRNMSMBA