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Remote Risk Evaluation and Mitigation Strategies (REMS) Manager

New Haven, CT 06510

Posted: 03/12/2025 Employment Type: Contract Job Category: Quality and Compliance Job Number: 618251 Is job remote?: Yes Country: United States

Job Description


The REMS manager will provide operational support for the delivery of Risk Evaluation and Mitigation Strategies (REMS) for the safety epidemiology and risk management group. The REMS manager will work closely with REMS team members to ensure REMS compliance, operational excellence and quality documentation is in place for the program.

ROLES AND RESPONSIBILITIES
  • Support delivery of REMS activities to agreed timelines according to company quality standards and REMS procedures.
  • Conduct reconciliation of various REMS data sources including compliance data, shipment data, Key performance indicator data to ensure proper oversight and compliance of the REMS program
  • Manage the REMS shared mailbox, respond to REMS queries and triage questions/issues as needed for resolution amongst REMS team members
  • Manage REMS specific issues and escalations, as applicable
  • Coordinate regular team meetings; track outstanding action items and activities per the project plan
  • Help manage and reconcile contracts, POs and invoices
  • Support REMS processes and procedures with execution of key deliverables

ESSENTIAL
  • Bachelors degree (preferably in medical or biological science) or equivalent by experience.
  • At least 5-7 years of relevant clinical/medical experience in the pharmaceutical industry, with experience in pharmacovigilance and/or quality assurance
  • Previous demonstration of basic project management skills including tracking deliverables
  • Strong communication skills and fluency in English
  • Prior experience tracking metrics and/or compliance and safety data including trending and interpreting data
  • Detail oriented and
  • Proficient in Microsoft applications
  • Broad knowledge and understanding of FDA regulations and compliance requirements in a GxP (Good [x] Practice) environment

DESIRABLE
  • Prior REMS experience
  • Project Management Certification
  • Audit or Inspection experience Working with third-party vendors

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About New Haven, CT

Ready to launch your career in the vibrant area around New Haven, Connecticut? Explore a plethora of exciting job opportunities in this bustling hub of innovation and culture. Boasting renowned landmarks like Yale University, the historic Shubert Theatre, and the stunning New Haven Green, this region offers a perfect blend of urban charm and natural beauty. With a thriving arts scene, delectable cuisines like the classic New Haven-style pizza, and an array of outdoor recreation options at East Rock Park and Long Wharf, this area is a haven for career growth and work-life balance. Join us in discovering the endless possibilities that await your professional journey in this enchanting corner of the Constitution State.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.