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Senior REMS Expert

2 months ago

Leigh, Wigan, United Kingdom Siri InfoSolutions Inc Full time

Job Title: Senior REMS Expert

Job Summary:

We are seeking a highly experienced Senior REMS Expert to join our team at Siri InfoSolutions Inc. As a Senior REMS Expert, you will be responsible for providing expert-level guidance and support in the development and implementation of Risk Evaluation and Mitigation Strategy (REMS) systems and tools.

Key Responsibilities:

  • Develop and implement REMS systems and tools to ensure compliance with FDA regulations and industry standards.
  • Provide expert-level guidance on risk evaluation and mitigation strategies to ensure the safe use of pharmaceutical products.
  • Collaborate with cross-functional teams to design and implement REMS systems that meet regulatory requirements.
  • Conduct periodic review reports and RMM tracking to ensure compliance with regulations and standards.
  • Stay up-to-date with industry developments and regulatory changes to ensure our REMS systems remain compliant.

Requirements:

  • 12+ years of experience in the healthcare domain with a strong background in risk management and regulatory compliance.
  • Proven experience in designing and implementing REMS systems and tools.
  • Deep knowledge of FDA REMS program requirements and key processes.
  • Experience with design and implementation of REMS systems and tools.
  • Good understanding of SDLC requirements and 21 CFR Part 11 GxP guidelines.
  • Prior experience of participating in designing and implementing REMS systems.
  • Experience of implementing or using CRM systems such as Salesforce Dynamics (highly advantageous).

What We Offer:

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced REMS expert looking for a new challenge, please submit your application.