Summary
Overview
Work History
Education
Skills
Timeline
Generic

SUZETTE HOBBS

Avenel,NJ

Summary

Risk Evaluation and Mitigation Strategies (REMS) Subject Matter Expert bringing a 15-year demonstrated track record of success in the pharmaceutical industry. Innovative pharmaceutical professional with a diverse background in risk management, drug safety, and customer service. A dedicated team player with developing leadership skills and a keen eye for detail while demonstrating the ability to resolve challenging situations in high-stress environments.

Overview

16
16
years of professional experience

Work History

REMS Specialist

Bristol Myers Squibb
Summit, NJ
11.2016 - Current
  • Collaborate with Senior Quality Compliance Coordinators or Hematology Consultants (HC) to resolve prescriber and pharmacy non-compliant issues
  • Assist Senior Quality Compliance Coordinators with inquiries regarding observations and deviations, prepare and submit CAPA documents and upload findings into RQO
  • Educate closed-distribution pharmacists and designees on Risk Management program requirements and dispensing guidelines, assist pharmacy counselors with ComplianceWire training accounts
  • Report Adverse Events per company guidelines
  • Helped the REMS Training Team with content creation for Compliance Cross-training
  • Assisted the REMS Training Team with content facilitation and live demonstrations to ensure learner retention
  • Mentor representatives after successful completion of training
  • Document progress and report findings to the Risk and Compliance Supervisor
  • Perform User Acceptance Testing (UAT) in preparation for system releases and enhancements
  • Enforce REMS program guidelines to ensure prescriber, patient and pharmacy compliance, and patient safety
  • Educate stakeholders on REMS guidelines for REMS products
  • Investigate and process enrollments for high-risk patients
  • Receive, review, and handle notifications identifying potential non-compliance with REMS program requirements
  • Conduct real-time intervention with prescribers to immediately resolve non-compliance issues with surveys and prevent prescription delays
  • Interact with Drug Safety, Medical Affairs, and Medical Customer Engagement departments to resolve medical cases involving suspected pregnancies, risk category assessments, and high dose requests exceeding the recommended dosing guidelines for REMS products
  • Prepare documents for medical review submissions to the appropriate department
  • Retrieve all pertinent patient medical history and documentation needed for resolution and liaison between the proper department and prescriber offices for all subsequent requests
  • Assess high-risk patients' medical history for risk category placement
  • Investigate, document, and resolve instances of non-compliance by patients, prescribers, and pharmacies
  • Handle escalated calls received from the Inbound team that requires intervention from an SME
  • Assist internal teams (Inbound, Registrations) as needed
  • Retain all knowledge within the REMS call center to efficiently perform daily tasks.
  • Worked flexible hours when needed
  • Completed paperwork, recognizing discrepancies and promptly addressing for resolution

Customer Care Specialist

Celgene Corporation
Summit, NJ
01.2007 - 11.2016
  • Support Physicians, Pharmacies, and Patients with general inquiries regarding The Risk Evaluation and Mitigation Strategies program as set forth by the FDA
  • Report all Adverse Events to the internal Medical Care Engagement Team as identified in the Standard Operation Procedures (SOPs)
  • Record and process customer complaints to ensure resolution
  • Process patient drug returns for proper disposal to ensure public safety
  • Assist Patients and Prescribers with REMS mandated surveys
  • Generated/processed Patient-Physician Agreement and Prescriber Enrollment Forms
  • Utilized Strategic Interaction Skills on each call to provide world-class service
  • Aided the Risk and Compliance Department with coverage as needed
  • Coach and mentor new representatives for the opening of call center positions.
  • Answered multiple calls, emails and faxes per day, addressing customer inquiries, solving problems and providing product information
  • Exceeded quality goal by carefully applying personal knowledge to address and correct problems

Verification Specialist

Celgene Corporation
Summit, NJ
10.2006 - 12.2006
  • Verified patient and prescriber enrollments to ensure accuracy
  • Recorded and corrected any errors found during the verification process and notified the appropriate party of findings
  • Generated/processed Patient-Physician Agreement and Prescriber Enrollment Forms
  • Assisted with outbound calls as needed

Registrations Representative

Celgene Corporation
Summit, NJ
06.2006 - 10.2006
  • Enrolled patients and prescribers into the applicable REMS Program
  • Reviewed enrollment forms to ensure REMS guidelines were met
  • Placed outbound calls to clarify information provided on the patient or prescriber enrollment forms
  • Sent fax confirmation once the registration process was complete.

Education

Bachelor of Science - Management-General Business

Kean University
Union, NJ
12.2022

Associate of Science - Liberal Arts and Sciences

Union County College
Cranford
07.2021

Skills

    Experience in leadership

    Team building

    Work ethic

    Reliable and trustworthy

    Training & Development

    Organizational skills

    Advanced presentation skills

    Constructive one-on-one coaching skills

    Microsoft Excel and Power Point

    Customer Satisfaction & Support

Timeline

REMS Specialist

Bristol Myers Squibb
11.2016 - Current

Customer Care Specialist

Celgene Corporation
01.2007 - 11.2016

Verification Specialist

Celgene Corporation
10.2006 - 12.2006

Registrations Representative

Celgene Corporation
06.2006 - 10.2006

Bachelor of Science - Management-General Business

Kean University

Associate of Science - Liberal Arts and Sciences

Union County College

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