Compliance & Validation

• 21 CFR Part 11 & Annex 11: Designing, configuring, and verifying electronic records and electronic signatures (ERES) within Veeva Vault and Salesforce environments to ensure absolute data integrity.

• Computer Software Validation (CSV): Executing end-to-end validation lifecycles following GAMP 5 methodologies, including Risk Assessments, User Requirement Specifications (URS), Functional Specifications (FS), and IQ/OQ/PQ execution.

• HIPAA & Global Privacy Compliance: Aligning Salesforce Health Cloud and IQVIA OCE architectures with stringent patient data privacy standards, secure encryption protocols, and robust PHI/PII data handling.

• Consent & Preference Management: Implementing reliable opt-in/opt-out mechanisms across omnichannel marketing platforms (Data Cloud, IQVIA OCE) to maintain continuous regional regulatory compliance.

Managing the controlled deployment of configuration changes, system release impacts (Veeva tri-annual updates), and maintaining the validated state of Content and Data models. 

Designing comprehensive system-level audit logs, field-level tracking, and automated monitoring guardrails across distributed architectures (Salesforce-to-SAP integrations). 

Establishing repeatable, automated testing strategies for continuous integration pipelines to guarantee that underlying compliant logic, validation rules, and sharing models remain fully intact during system upgrades.