Drug Safety Specialist Role at Parexel, India (Remote) - PHARMA STUFF

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Aug 6, 2024

Drug Safety Specialist Role at Parexel, India (Remote)

Parexel Hiring Drug Safety Specialist: Elevate Your Career in Medical Sciences Introduction: Embark on an exciting career journey with Parexel, a renowned player in the pharmaceutical and healthcare industry. Discover exceptional opportunities as a Drug Safety Specialist, where your expertise will be valued in ensuring regulatory compliance and contributing to the overall success of our operations.

About the Parexel:

Parexel is a global clinical research organization that focuses on providing innovative solutions to advance the development of new medical therapies. With a commitment to excellence, Parexel plays a crucial role in facilitating drug development, ensuring safety, and improving patient outcomes. Join our team of dedicated professionals who are driving positive change in the healthcare landscape.

Company Vacancies List:

| Position Title | Drug Safety Specialist Location: India, Remote Job ID: R0000018999 Category: Medical Sciences

Job Description:

As a Drug Safety Specialist at Parexel, you will be responsible for:
  • Validating and maintaining regulatory information.
  • Performing xEVMPD submissions via Veeva Vault & EVWEB.
  • Tracking the status of acknowledgments received.
  • Demonstrating knowledge of the European regulatory framework, including SmPC.
  • Understanding XEVMPD and IDMP requirements and regulations.
  • Handling Art.57 QC queries from EMA.
  • Ensuring compliance with regulatory obligations, including XEVMPD and IDMP.
  • Utilizing expertise in Microsoft 365 Apps for data handling and communication.

Role and Responsibilities:

  • Validate and maintain regulatory information.
  • Perform xEVMPD submissions via Veeva Vault & EVWEB.
  • Track the status of acknowledgments received.
  • Demonstrate knowledge of the European regulatory framework.
  • Handle Art.57 QC queries from EMA.
  • Ensure compliance with regulatory obligations, including XEVMPD and IDMP.
  • Utilize expertise in Microsoft 365 Apps for data handling and communication.
https://pharmastuff.org.in/job/parexel-hiring-drug-safety-specialist

 

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