Bachelor's or Master's degree in Engineering, Technology, Life Sciences, or Pharmacy preferred.
10+ years of experience in Veeva Vault Safety administration, support, or implementation.
Strong understanding of Veeva Vault Safety including workflow configuration.
Solid grasp of pharmacovigilance processes, particularly ICSR case processing.
Hands-on experience with SDLC processes and Veeva platform features.
Knowledge of GxP compliance and related audit processes.
Strong analytical and problem-solving skills.
Responsibilities
Administer and maintain Veeva Vault Safety applications and workflows.
Support implementation and maintenance of Veeva Safety features.
Manage and troubleshoot support tickets and system issues.
Participate in system updates and validation support activities.
Ensure compliance with GxP and regulatory safety requirements.
Collaborate with teams to gather requirements for system improvements.
Conduct user training and provide support for Veeva Safety applications.
Benefits
Comprehensive support for professional development and certifications.
Collaborative work environment with cross-functional teams.
Opportunities to lead system enhancements and compliance initiatives.
Focus on maintaining high standards of compliance and data integrity.
Engagement in audit and inspection readiness activities.
Full Job Description
Job Summary:
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.
Education & Experience:
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.
