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Veeva Safety Specialist

Karwell TechnologiesBoston, MA
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Overview

Remote
On-site

Job Description

Job Description:
  • The Veeva Safety Specialist will be responsible for the implementation, administration, configuration, and ongoing support of Veeva Vault Safety solutions within a pharmaceutical or life sciences environment.
  • This role involves managing safety processes, resolving system issues, supporting regulatory compliance activities, and ensuring smooth operation of safety workflows on the Veeva Vault platform.
  • The specialist will collaborate with cross-functional teams to support pharmacovigilance operations, system enhancements, audit readiness, and compliance initiatives while maintaining high standards of GxP compliance and data integrity.

Roles & Responsibilities:

  • Administer, configure, and maintain Veeva Vault Safety applications, including account management, workflows, issue resolution, transmission records, and regulatory submissions.
  • Support implementation and ongoing maintenance activities for Veeva Safety and related platform features.
  • Manage and troubleshoot support tickets, system issues, and enhancement requests within the Veeva environment.
  • Participate in SDLC activities, system updates, Release Impact Assessments (RIA), and validation support.
  • Support safety and compliance processes, including change control, deviation management, CAPA workflows, periodic reviews, and user access reviews.
  • Ensure system compliance with GxP and regulatory requirements for pharmacovigilance and safety operations.
  • Collaborate with business users, IT teams, and stakeholders to gather requirements and implement system improvements.
  • Monitor system performance and maintain system documentation, SOPs, and user manuals.
  • Conduct user training sessions and provide end-user support for Veeva Safety applications.
  • Analyze data, troubleshoot system issues, and provide data-driven recommendations for process improvements.
  • Support audit and inspection readiness activities related to Veeva Safety and safety operations.
  • Maintain effective communication and knowledge sharing across project and operational teams.

Requirements:

  • Bachelor's or Master's degree in Engineering, Technology, Life Sciences, Pharmacy, or related field preferred.
  • 10+ years of experience in Veeva Vault Safety administration, support, or implementation within pharmaceutical or life sciences organizations.
  • Strong experience with Veeva Vault Safety, including workflow configuration, issue resolution, and regulatory submission processes.
  • Good understanding of pharmacovigilance processes, including ICSR case processing and safety operations.
  • Hands-on experience with SDLC processes, Release Impact Assessment (RIA), and Veeva platform features.
  • Knowledge of GxP compliance, CAPA, deviation management, change control, and audit processes.
  • Strong analytical, troubleshooting, and problem-solving skills.
  • Excellent communication, documentation, and collaboration skills.
  • Preferred Certifications:
    • Veeva Technical Foundation Certification
    • Administer Veeva Safety Certification

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FAQs About Veeva Safety Specialist Jobs at Karwell Technologies

What is the work location for this position at Karwell Technologies?
This job at Karwell Technologies is located in Boston, MA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Karwell Technologies?
Employer has not shared pay details for this role.
What employment applies to this position at Karwell Technologies?
The employer has not provided this information. This may be discussed during the hiring process.
What is the process to apply for this position at Karwell Technologies?
You can apply for this role at Karwell Technologies either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.