Pharmacovigilance

Illuminate drug safety reporting with our end-to-end pharmacovigilance services.

Alphanumeric helps Life Sciences organizations operate, scale, and sustain compliant Pharmacovigilance programs, supporting adverse event processing, safety surveillance, and regulatory reporting from early clinical development through post-market lifecycle management.

We deliver complete, end-to-end Pharmacovigilance operations, supporting the design, execution, oversight, and continuous optimization of global PV programs from first-in-human studies through post-market lifecycle management.

Our services span the entire PV operating model—from system configuration and case intake, through ongoing safety surveillance and aggregate reporting, to quality oversight, audit readiness, and regulatory inspection support—ensuring sustained compliance with ICH, GVP, and FDA requirements.

Service Engagement Models

Alphanumeric offers flexible models to meet different client needs:

Full-Service Outsourcing (End-to-End PV): Ideal for small to mid-size biotech without an internal PV department.
Functional Service Provider (FSP) Model: For mid-to-large biopharma with partial PV infrastructure.
Hybrid/Co-Managed Model: For companies in transition (e.g., moving from clinical to commercial).
Project-Based/Ad Hoc Support: For sponsors needing short-term PV deliverables or gap-filling.

Core Offerings

Case Management & Individual Case Safety Report (ICSR) Processing

Set the foundation for a successful PV program with structured documentation and oversight:

End-to-end ICSR case processing (clinical and post-marketing)
Adverse event intake, triage, data entry, and medical coding (MedDRA, WHO-DD)
Case quality review, reconciliation, and submission readiness
Expedited and non-expedited reporting to Health Authorities
Case follow-up management and query resolution
Vendor and CRO oversight to ensure consistent case handling standards

Pharmacovigilance Platform Configuration & System Set-Up

Enable efficient, compliant safety operations through fit-for-purpose PV systems:

Safety database configuration and implementation (clinical and post-marketing)
Workflow design aligned to SOPs, regulatory timelines, and inspection expectations
User role definition, access controls, and audit trail configuration
Case processing, reporting, and submission rule set-up
Integration support with EDC, CTMS, call centers, and partner systems
UAT planning and execution support to validate PV system readiness
System change management, upgrades, and configuration optimization

SOP Development, PV Strategy & Program Management

Set the operational foundation for a compliant and inspection-ready PV program:

Authoring and maintaining PV SOPs, policies, job descriptions, and work instructions
Supporting organizations as they scale from start-up to mid-size and global operations
Conducting PV gap assessments, system evaluations, and maturity assessments
Project managing the creation, implementation, and maintenance of PV documentation
Supporting PV system implementation, upgrades, and process optimization

Signal Management & Safety Surveillance

Enable proactive identification and assessment of safety risks:

Routine signal detection and monitoring activities
Signal validation, prioritization, and documentation support
Safety issue tracking and escalation workflows
Drafting responses to Health Authority safety inquiries
Supporting ad hoc safety evaluations and regulatory safety actions

Aggregate Reports & Risk Management Planning

Ensure consistent and compliant aggregate safety reporting across global markets:

Authoring and maintaining DSURs (Development Safety Update Reports)
Preparing PBRERs/PSURs (Periodic Benefit-Risk Evaluation Reports)
Supporting IND Annual Reports and regional aggregate submissions
Developing and maintaining Risk Management Plans (RMPs) and safety sections
Aligning aggregate reporting with ongoing signal and risk evaluations

Audit Support, Inspection Readiness & Quality Oversight

Demonstrate operational compliance and inspection preparedness:

Conducting PV audits, vendor audits, and mock regulatory inspections
Implementing QC checklists and real-time quality review processes
Supporting CAPA development and inspection responses
Designing and executing ongoing PV quality monitoring plans

Regulatory Intelligence & Compliance Monitoring

Stay aligned with evolving global PV requirements:

Monitoring Health Authority guidance, Cortellis, Tarius, and regulatory updates
Performing impact assessments for new or changing PV regulations
Maintaining a living tracker of global PV regulatory intelligence
Translating regulatory changes into operational actions and SOP updates

Clinical Trial Safety Operations

Support safety activities across clinical development programs:

SAE reconciliation across EDC, safety databases, and CRO systems
Tracking safety submissions to Health Authorities, Ethics Committees, and IRBs
Coordinating routine safety deliverables across studies
Supporting sponsor oversight and compliance across trial portfolios

Partnering with Alphanumeric Experts Drives Better Outcomes

100% clean audit record for client projects.

100% compliance with E2B submissions across global safety databases.

100% regulatory compliance rate with global PV regulations (FDA, EMA, MHRA, PMDA, etc.).