Veeva RIMS Security consultantAVEVA Controls Engineer

Role: Veeva RIMS Security consultantAVEVA Controls Engineer

Work location: Remote

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 client'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