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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.
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