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Rems Specialist Jobs (NOW HIRING)

Tennessee Oncology

The Risk Evaluation and Mitigation Strategies (REMS) Program Specialist is a licensed nurse that is responsible for ensuring program compliance and completion of all REMS requirements in addition to ...

Rems-Murr-Kliniken gGmbH

$13.75 - $16.25/hr

... Rems-Murr-Klinikum Winnenden und der Rems-Murr-Klinik Schorndorf leisten wir eine qualifizierte Zentral- und Regelversorgung für die Menschen im Rems-Murr-Kreis und darüber hinaus. In 26 ...

American Oncology Network, Inc.

$75.13/hr

## Pharmacy Nurse Specialist - RNApplylocations: United Statestime type: Full timeposted on: Posted ... KPA 2 -*** REMS Authorizations and safety information***.**** Responsible for assisting the ...

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Rems Specialist information

What is a REMS specialist?

REMS Specialists are professionals responsible for implementing and managing Risk Evaluation and Mitigation Strategies (REMS) as mandated by the U.S. Food and Drug Administration (FDA) for certain medications. Their role involves ensuring that pharmaceutical companies, healthcare providers, and patients comply with specific safety requirements designed to minimize risks associated with particular drugs. REMS Specialists coordinate education, training, monitoring, and reporting activities to guarantee that all stakeholders follow the prescribed safety protocols. They play a critical role in patient safety and regulatory compliance within the pharmaceutical industry.

What skills and qualifications are needed to thrive as a REMS specialist?

To thrive as a REMS Specialist, you need a strong background in pharmaceutical regulations, risk management, and healthcare compliance, often supported by a degree in pharmacy, nursing, or a related field. Familiarity with REMS (Risk Evaluation and Mitigation Strategies) program management systems, FDA reporting tools, and data tracking software is typically required. Excellent communication, attention to detail, and problem-solving abilities are vital soft skills for coordinating stakeholders and ensuring regulatory adherence. These skills are crucial for minimizing medication risks, maintaining patient safety, and ensuring organizational compliance with regulatory requirements.

What are common challenges a REMS specialist faces when ensuring compliance with Risk Evaluation and Mitigation Strategies programs?

A REMS Specialist often navigates complex regulatory requirements while coordinating between pharmaceutical companies, healthcare providers, and internal teams. One common challenge is maintaining up-to-date knowledge of evolving FDA guidelines and ensuring all stakeholders are promptly informed about changes. Additionally, accurately tracking documentation and reporting outcomes can be demanding due to the detailed nature of compliance. Effective communication and strong organizational skills are essential to overcoming these challenges and ensuring REMS program success.

What is the difference between Rems Specialist vs Rems Coordinator?

AspectRems SpecialistRems Coordinator
CertificationsOSHA, OSHA 10/30, HAZWOPEROSHA, OSHA 10/30, HAZWOPER
Work EnvironmentIndustrial sites, manufacturing plantsIndustrial sites, manufacturing plants
Job FocusImplementing and maintaining REMS programsCoordinating REMS activities and compliance

The Rems Specialist primarily focuses on implementing and maintaining REMS programs, ensuring compliance with regulations. The Rems Coordinator manages the coordination of REMS activities across teams, facilitating communication and documentation. Both roles require similar certifications and work environments, but their core responsibilities differ in focus and scope.

What is the role of the Rems Specialist program?

A REMS Specialist manages and oversees Risk Evaluation and Mitigation Strategies (REMS) programs to ensure medication safety and compliance with regulatory requirements. They coordinate with healthcare providers, monitor program effectiveness, and maintain documentation to mitigate risks associated with specific drugs or treatments.
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Rems Specialist jobs near you
Infographic showing various Rems Specialist job openings in the United States as of August 2026, with employment types broken down into 80% Full Time, and 20% Part Time. Highlights an 100% In-person job distribution.

Virtual Patient Support Specialist

Avery Healthcare Group Ltd.

Phoenix, AZ • On-site

Other

Medical, Dental, Vision, Retirement, PTO

Re-posted 15 days ago

Job description

REMS Specialist

You're a proactive problem-solver and have the ability to make customers feel like your friend.

In this role as a REMS Specialist, you will be responsible for answering non-clinical related questions as well as triaging adverse events and product complaints utilizing an FAQ document and then entering the data into the CRM. The 8 hour shift will rotate between 8am - 8pm EST.

You will:

  • Complete follow-up for missing/updated information from stakeholders (patients, healthcare providers, pharmacies, etc.), including data entry processing, documentation, and safety reporting per program guidelines.
  • Ensure document/data processing, data corrections and all communication are documented accurately, concisely and in a timely manner.
  • Maintain a working knowledge of program guidelines, product or disease state for the assigned program(s).
  • Conduct pre and post call analysis of calls.
  • Answer incoming calls and perform outgoing calls in professional manner following client guidelines and business rules.
  • Identify any areas that are potentially troublesome and follow up with the stakeholder to ensure that issue is resolved.

Job Qualifications: Education

  • Bachelor's Degree highly preferred or 1+ year of healthcare call center experience.

Required Skills

  • 1+ years recent pharmaceutical or healthcare industry experience- e.g. Medical Assistant, Nurse's Aide, EMT, health insurance company etc. is highly preferred.
  • Working knowledge of medical terminology
  • Case management experience
  • Solid written and verbal communication skills and listening skills.
  • Ability to type 40+ words per minute (wpm)
  • Efficient computer and data entry skills; ability to learn new systems and programs quickly.
  • Excellent attention to detail
  • Ability to prioritize and reprioritize workload depending on program needs.

Preferred Skills

  • 1+ year in pharmaceutical or healthcare call center with Risk Evaluation and Mitigation Strategy (REMS) experience highly preferred.

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway. At times, we will consider transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.

Why Syneos Health? Here, the work is challenging, and the pace is exhilarating. By joining one of our commercial teams, you're empowered to succeed with the support, resources, and autonomy that you need. The diversification and breadth of our new and existing partnerships create a multitude of career paths and employment opportunities. Syneos Health has launched more sales teams in the last 5 years across all major therapeutic areas than the top 25 pharma companies combined. Join our game-changing, global company dedicated to creating better, smarter, faster ways to get biopharmaceutical therapies to patients. Experience the thrill of knowing that your everyday efforts are contributing to improving patients' lives around the world.

W o r k H e r e M a t t e r s E v e r y w h e r e | How are you inspired to change lives?

Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled)

The benefits for this position will include a competitive compensation package, Health benefits to include Medical, Dental and Vision, Company match 401k, flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos Health complies with all applicable federal, state, and municipal paid sick time requirements.

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