Overview
Skills
Job Details
Job Description:
We are looking for an experienced Veeva Vault Safety Consultant to support the implementation and optimization of Veeva Vault Safety a cloud-based pharmacovigilance system. The ideal candidate should have a strong background in drug safety operations, safety systems, and life sciences compliance.
Key Responsibilities:
Lead or support implementation and configuration of Veeva Vault Safety platform.
Manage system setup, case processing workflows, reporting rules, and regulatory submission configuration.
Collaborate with pharmacovigilance teams to gather business requirements and ensure system alignment.
Assist in validation activities, including URS, IQ, OQ, PQ, and documentation.
Integrate Vault Safety with other safety systems or clinical data platforms.
Ensure data compliance with GxP, ICH, FDA, and EMA safety regulations.
Configure safety data workflows, including case intake, triage, assessment, and regulatory reporting.
Provide end-user training and support.
Troubleshoot system issues and liaise with Veeva support teams.
Contribute to process improvements and best practices for safety system use.
Required Skills:
Hands-on experience with Veeva Vault Safety Suite (preferred).
Good understanding of pharmacovigilance processes and regulatory reporting.
Knowledge of global safety requirements (e.g., E2B(R3), MedDRA, WHO-DD, Argus).
Experience with system validation and compliance (21 CFR Part 11, GAMP5).
Strong documentation, communication, and stakeholder management skills.
Experience with safety system migration or integration is a plus.
Veeva Vault certification is a strong plus.