Veeva RIM

Your key responsibilities:

• Lead the configuration, customization, and deployment of Veeva Vault RIM (Registrations, Submissions, Submission Planning, Archive), ensuring alignment with pharmaceutical quality standards and regulatory frameworks.
• Architect and oversee the development of workflows, object lifecycles, security models, and page layouts, enabling scalable and compliant Vault implementations.
• Deep understanding of PV regulations and guidelines, including ICH E2E, FDA, EMA, GVP Modules, and other international standards.
• Oversee end-to-end PV operations, including case intake, processing, case triaging, medical review, signal detection, risk management, and aggregate reporting
• Lead RIMS implementation projects, ensuring seamless integration with other enterprise systems and compliance with data standards (e.g., IDMP, xEVMPD).
• Support integration and interoperability between Vault Safety, RIM, and external PV systems (e.g., Argus, E2B gateways, clinical systems).
• Ensure compliance with global safety regulations including FDA, EMA, ICH (E2B, E2C, E2D), and regional pharmacovigilance requirements.
• Engage with cross-functional stakeholders (Quality, Regulatory, IT, Business) to gather and translate complex requirements into functional and strategic Vault configurations.
• Direct data migration and integration initiatives, ensuring seamless connectivity between Veeva Vault and enterprise systems such as Clinical, QMS and other Document Management platforms.
• Establish and maintain comprehensive system documentation, including design specifications, configuration guides, validation protocols (IQ/OQ/PQ), and audit-ready deliverables.
• Provide leadership in issue resolution and impact analysis, guiding teams through troubleshooting and change management processes.
• Ensure system compliance with GxP, CSV/CSA, and 21 CFR Part 11 regulations, embedding validation best practices throughout the development lifecycle.
• Manage release cycles and testing activities, including sandbox coordination, regression testing, and production deployments.
• Act as a strategic consultant to internal and external stakeholders, advising on Vault capabilities, optimization opportunities, and digital transformation initiatives.
• Engage with client stakeholders, understand their challenges, and propose innovative digital solutions in the RA and PV space that enhance compliance and efficiency.
• Mentor and lead a team of Vault developers and analysts, fostering a culture of innovation, collaboration, and continuous improvement.