Veeva Safety Specialist

• 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