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.