Pharmacovigilance

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


Alphanumeric helps Life Sciences organizations monitor and report adverse events with clarity, consistency, and compliance — from early-phase development through post-market surveillance.

Like the phases of the moon, drug safety unfolds over time. Our expert Pharmacovigilance (PV) services support every step of that journey, delivering timely, accurate documentation and insight to meet regulatory expectations and ensure quality oversight.

Core Offerings

SOP Development, Strategy & Project Management

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

  • Authoring SOPs, policies, job descriptions, and work instructions
  • Supporting organizations as they scale from start-up to mid-size and beyond
  • Conducting gap assessments and strategic evaluations
  • Project managing the creation and submission of safety documentation

Signal Management & Safety Response Support

Support safety teams with organized, responsive reporting workflows:

  • Conducting signal monitoring activities
  • Drafting timely responses to Health Authority inquiries
  • Assisting with ad hoc safety-related submissions and documentation

Aggregate Reports & Risk Management Plans

Ensure timely and compliant reporting across global markets:

  • Authoring DSURs (Drug Safety Update Reports)
  • Preparing PBRERs (Periodic Benefit Risk Evaluation Reports)
  • Submitting IND Annual Reports and Risk Management Plans

Audit Support, Inspection Readiness & Quality Monitoring

Demonstrate compliance and prepare confidently for scrutiny:

  • Performing GCP and PV audits and mock inspections
  • Implementing QC checklists and real-time quality review processes
  • Developing robust quality monitoring plans for ongoing success

Regulatory Intelligence Monitoring

Stay ahead of shifting global regulatory requirements:

  • Monitoring HA websites, Cortellis, and Tarius for PV updates
  • Performing impact assessments on regulatory changes
  • Maintaining a living tracker of global regulatory intelligence

Clinical Trial Safety Services

Support safety operations during clinical development:

  • Performing SAE reconciliations across systems and CROs
  • Tracking safety submissions to HAs, Ethics Committees, and IRBs
  • Coordinating routine safety activities across studies to support compliance and sponsor oversight
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Let Us Be the Constant in Your Safety Operations Orbit


Alphanumeric is your trusted partner for full-service Pharmacovigilance monitoring and reporting. Whether you’re growing your safety team or preparing for inspections, we’ll help you navigate each phase with confidence.

Partnering with Alphanumeric Experts Drives Better Outcomes

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100% clean audit record for client projects.
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100% compliance with E2B submissions across global safety databases.
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100% regulatory compliance rate with global PV regulations (FDA, EMA, MHRA, PMDA, etc.).

Contact Us to Get Started