Job Description:
The Veeva Regulatory Information Management (RIM) Security Consultant is a specialized expert responsible for designing, implementing, and maintaining the security architecture within Veeva RIM. This role ensures that access controls, security profiles, and permission sets align with regulatory compliance requirements, business needs, and organizational policies including distributor management frameworks and US DOJ (Department of Justice) restrictions.
Key Responsibilities:
" Key Responsibilities
Security Architecture & Administration
Design and maintain Veeva RIM security models, including roles, profiles, permission sets, and sharing rules
Develop and enforce user access governance across all RIM modules: Submissions, Submissions Archive, Registrations including xEVMPD/IDMP
Manage lifecycle state security and record level access controls within Vault RIM
Distributor & Third-Party Access Management
Design and implement security models for managing distributor access within Veeva RIM, ensuring appropriate data visibility and restrictions
Define and enforce data segregation rules to prevent unauthorized access to sensitive regulatory content by third-party partners
Collaborate with Legal, Compliance, and Regulatory Affairs teams to align distributor access with contractual and regulatory obligations
DOJ Restrictions & Compliance
Implement and maintain DOJ-mandated access restrictions within the Veeva RIM security framework
Ensure security configurations support regulatory compliance obligations, including consent decrees, corporate integrity agreements, and other legal constraints
Partner with Legal and Compliance teams to translate DOJ requirements into actionable Vault security configurations
Maintain thorough documentation and audit trails to demonstrate compliance during inspections or audits
Platform Configuration & Support
Serve as the subject matter expert (SME) for Veeva RIM security across global regulatory teams
Troubleshoot and resolve security-related issues including access errors, permission conflicts, and workflow bottlenecks
Support role assignment in alignment with the principle of least privilege
Collaborate with Digital, and Regulatory Operations Capability teams on system upgrades, releases, and security patches
Governance & Documentation
Maintain up-to-date security model documentation, including role matrices, permission set inventories, and access control policies
Develop and deliver training materials for end users and administrators on security best practices within Veeva RIM
Participate in change control processes for any modifications to the security model
Support validation activities (CSV/GxP) related to security configuration changes
"
What are the Mandatory skills and skill proficiencies required for this position?
"Requirement Details
Experience Minimum 5 years of hands-on experience with Veeva RIM with experience on the security aspects within the system
Veeva RIM Expertise Deep knowledge of Veeva Vault RIM modules: Submissions, Submissions Archive, Registrations
Security Model Expertise Proven experience designing and managing Vault security profiles, roles, permission sets, and atomic security (lifecycle state security, object-level permissions, field-level security)
Distributor Management Demonstrated experience configuring security models for external/distributor user access within Veeva RIM
DOJ Restrictions Familiarity with implementing DOJ security models in a regulated pharmaceutical environment
Regulatory Knowledge Understanding of Global Regulatory Affairs processes, eCTD submissions, Health Authority communications, and xEVMPD/IDMP
GxP/Compliance Experience working in GxP-regulated environments with knowledge of 21 CFR Part 11, Annex 11, and data integrity principles
Education Bachelor's degree in Life Sciences, Information Technology, Computer Science, or a related field
"
What are the Optional skills and skill proficiencies for this position?
" Veeva Vault RIM certification(s) (e.g., Vault Administrator, Vault RIM)
Experience with Sanofi's Vault RIM implementation or similar large-scale pharma deployments
Familiarity with integration layers connecting Vault RIM to other enterprise systems
Knowledge of XEVMPD/IDMP regulatory data standards
Experience supporting regulatory inspections or audits involving system security reviews
Good documentation skills
GxP experience
Good communication skills
Stakeholder management (Regulatory, Legal, Compliance, Digital, QA)
Analytical & troubleshooting skills
Ability to translate business rules into security configuration
"
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
- Dice Id: 91128170
- Position Id: OOJ - 12408-11409-1775757799
- Posted 8 hours ago
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