Safety & Pharmacovigilance Transformation
Strengthening pharmacovigilance operations through data, technology and AI from case intake to signal detection and regulatory compliance.
Pharmacovigilance excellence
Deep pharmacovigilance expertise combined with technology and data capabilities to modernise safety operations.
End-to-end safety support
From safety strategy and operating model design to system implementation and managed services.
Veeva Safety expertise
BASE life science consultants have completed dedicated Veeva Safety business and administrator training, ensuring our teams are fully equipped to support implementation, optimisation and operations.
Future-ready PV operations
AI-enabled automation, scalable safety platforms and modern data governance designed for evolving regulatory requirements.
Veeva Safety Expertise
As pharmacovigilance organisations modernise their safety systems, many are adopting Veeva Safety as a cloud-based platform to support case processing, regulatory reporting and signal management.
BASE Life Science supports clients across the full lifecycle of Veeva Safety programs, from strategy and implementation to operational optimisation.
Our teams completed a comprehensive Veeva Safety enablement program covering both pharmacovigilance processes and platform configuration, ensuring consultants understand both the functional pharmacovigilance processes and the platform configuration model.
Our expertise includes:
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Veeva Safety implementation and configuration
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Case processing workflow design
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Integration with regulatory and clinical systems
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Safety data migration from legacy systems
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Validation and regulatory compliance support
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System optimisation and release management
With deep expertise in the Veeva ecosystem, BASE helps organisations deploy safety platforms that are compliant, scalable and aligned with evolving pharmacovigilance requirements.
Our Offerings
Advisory & Consulting
Pharmacovigilance organisations are under increasing pressure to process growing safety data volumes while maintaining strict regulatory compliance. BASE supports life sciences companies in designing modern PV operating models that balance compliance, efficiency and innovation.
Safety operating model assessment
Understanding the maturity of safety processes, systems and governance is essential for transformation. BASE performs structured assessments across people, processes, data and technology to identify gaps, benchmark industry practices and define a pragmatic roadmap for improvement.
Safety system strategy & vendor selection
Selecting the right pharmacovigilance platform is a critical decision impacting safety operations for years. BASE supports organisations through the full selection process including:
- Market analysis
- Vendor evaluation
- Proof of concept and CRP support
- Contract and implementation planning
Our team has deep experience across leading PV platforms including Veeva Safety, Argus Safety and integrated safety ecosystems.
PV process optimisation
Inefficient safety workflows increase operational risk and delay case processing timelines. BASE maps existing processes, identifies bottlenecks and redesigns workflows to improve compliance, efficiency and inspection readiness.
Japan PV rollout advisory
Rolling out pharmacovigilance platforms to Japan often introduces additional complexity due to local regulatory requirements and reporting expectations from the Pharmaceuticals and Medical Devices Agency (PMDA). BASE helps organisations prepare Japan deployments by aligning global safety processes with local PV requirements, assessing system readiness and supporting rollout planning to ensure compliant and efficient operations.
AI & Automation
Pharmacovigilance teams must process increasing volumes of safety data while maintaining strict regulatory and privacy requirements. BASE applies AI and automation to reduce manual effort, improve data quality and accelerate pharmacovigilance workflows while ensuring compliance with global safety regulations.
PII Redaction for Safety Documents
Safety documentation often contains sensitive personal information that must be protected to comply with global privacy regulations such as GDPR.
Our AI-powered redaction solution automatically identifies and removes personally identifiable information (PII) from safety documents including case narratives, medical reports and regulatory submissions.
The solution detects names, contact information, addresses and other sensitive data across structured and unstructured documents while preserving the clinical context of the content.
Automated Translation for Global Case Processing
Pharmacovigilance teams receive safety reports in multiple languages from global sources including healthcare professionals, patients and regulatory authorities.
Our AI-enabled translation solution rapidly translates safety documentation while preserving medical terminology and pharmacovigilance context. This enables safety teams to review cases faster, improves case intake timelines and reduces reliance on manual translation processes.
The solution supports integration with safety systems and document repositories to streamline the processing of multilingual safety data.
Health Authority Query Assistant
Responding to health authority queries requires analysing large volumes of regulatory and safety documentation under strict timelines.
Our AI solution extracts relevant information from safety reports, regulatory submissions and internal documentation to support draft response preparation and evidence identification. Safety and regulatory teams can focus on reviewing and validating responses rather than manually searching for information.
Safety Narrative Generation
Generating safety narratives requires consolidating information from multiple case data fields and medical reports.
AI-assisted narrative drafting helps safety professionals generate structured narrative drafts directly from case data, improving consistency and reducing narrative preparation time while maintaining regulatory standards.
Data & Insights
Effective pharmacovigilance depends on trusted data. BASE helps organisations build strong safety data foundations to support signal detection, regulatory reporting and compliance.
Safety Master Data Governance
We implement governance frameworks that ensure safety data consistency across case processing systems, regulatory platforms and analytics environments. This supports reliable signal detection, regulatory submissions and cross-system integration.
Signal Detection & Analytics Enablement
BASE life science supports the implementation of advanced analytics environments that enable safety teams to monitor safety signals, evaluate risk patterns and generate insights from global safety data.
Safety Data Integration
Pharmacovigilance systems rarely operate in isolation. BASE designs integrations between safety platforms, clinical systems, regulatory systems and data lakes to ensure consistent and traceable data exchange.
Data Migration
Safety data migrations are complex due to regulatory requirements, audit requirements and legacy system structures.
Safety Data Cleansing & Enrichment
Before migration, BASE performs detailed data profiling and cleansing to identify inconsistencies, duplicates and missing information within safety databases.
BASE Migration Framework
All migrations leverage the BASE Migration Framework, our standard approach for regulated data migrations. The framework ensures:
- Full traceability
- Validated migration processes
- Regulatory compliance
- Transparent delivery governance
The framework has been successfully applied across multiple safety system migrations including Argus to Veeva Safety transformations.
Data Integrity Assurance
BASE ensures that all safety data maintains ALCOA+ principles, preserving data authenticity, integrity and auditability throughout the migration lifecycle.
End-to-end Implementation
BASE life science provides full lifecycle support for implementing and optimising pharmacovigilance platforms including Veeva Safety, Oracle Argus and ArisGlobal safety systems.
Our services include:
- Safety system implementation and configuration
- System integration and data flows
- Safety data migration
- Validation and compliance documentation
- User training and adoption support
Our consultants combine deep pharmacovigilance expertise with technical platform capabilities, enabling successful system deployments and operational improvements.
Managed Services
Safety Platform Operations (L2/L3 support)
BASE provides ongoing support for pharmacovigilance platforms, ensuring operational stability and regulatory compliance.
Our services include:
- Incident and service request management
- System monitoring and optimisation
- Release management and enhancements
- Regulatory compliance monitoring
With dedicated support teams and PV expertise, we help organisations maintain efficient and compliant safety operations.
BASE life science combines pharmacovigilance expertise, technology capabilities and regulatory understanding to support modern safety organisations.
Our differentiators include:
- Deep domain expertise across Safety, Regulatory and Clinical R&D operations
- Strong partnership with Veeva Systems and experience across the Veeva Vault ecosystem
- Proven delivery in regulated environments with strict compliance requirements
- AI innovation focused on practical, regulatory-compliant use cases
- Scalable delivery models including implementation and managed services
By combining safety domain knowledge with advanced technology capabilities, BASE helps organisations modernise pharmacovigilance operations while maintaining the highest standards of regulatory compliance.
