Hybrid Senior Manager, Patient Support Program – Vigilance

at Fresenius Kabi USA

• Job title: Senior Manager, Patient Support Program – Vigilance
• Job type: Full Time
• Experience level: Senior
• Salary: $159,000 - $165,000 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Lake Zurich, United States

About the role

• Senior Manager leading US Vigilance activities for Biosimilars at Fresenius Kabi. Managing pharmacovigilance standards and ensuring regulatory compliance across departments.

Responsibilities

• Lead all activities relative to pharmacovigilance activities with Fresenius Kabi USA biosimilar business partners, both locally and globally.
• Establish relationships, and safety and data exchange agreements (SDEA) with business partners and HUB services, serving as the primary liaison ensuring they meet all global and local regulations, policies, and procedures.
• Drive new initiatives, establishing project timelines and key goals, ensuring Vigilance participation on global and local due diligence evaluations.
• Responsible for ensuring the execution and implementation of SDEA, directly supports, and provides oversight of all data exchange and reconciliation activities.
• Responsible for oversight of Risk Evaluation and Mitigation Strategy program for biosimilars ensuring execution of program requirements collaborating with vendor and cross functional teams.
• Responsible for writing and/or review of applicable Standard Operating Procedures (SOPs).
• Identifies new procedures needed and changes to be made to established procedures to implement programs.
• Ensure that all global and local procedures are in alignment.
• Train and mentor staff regarding all established procedures and agreements.
• Work cross-functionally within the Global Vigilance team, supporting all PSP Vigilance activities, as needed.
• Review and approve adverse event information entered into the global complaint management workflow (gCMW).
• 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 degree strongly preferred (e.g., PharmD, RPh, RN)
• Advanced degree (PharmD, MS, or MBA) preferred
• 8+ years of experience in the pharmaceutical industry, in a drug safety or pharmacovigilance department required
• Experience with Patient Support Programs required
• 3+ years of management experience or experience leading successful teams required
• Pharmacovigilance, post-marketed adverse drug event reporting experience required
• Global experience preferred
• Knowledge of PC systems, adverse event databases, and Microsoft Office Suite (Word, Excel) required
• ARIS global system experience is preferred
• Understands 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.

Benefits

• 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.