Senior Project Manager, Vigilance
Fresenius Kabi USA
full-time
Posted on:
Location Type: Hybrid
Location: Lake Zurich • Illinois • United States
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Salary
💰 $155,000 - $185,000 per year
Job Level
About the role
- 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
- 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
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
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