Senior Project Manager (Vigilance)

• 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.

Job 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.

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.

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.