This document summarizes expertise in pharmacovigilance (PV) including: 1) Establishing PV departments, procedures for adverse event reporting, and process improvements. 2) Expanding globally and launching new products, including creating affiliate PV departments and ensuring compliance. 3) Managing quality systems with SOPs, audits, compliance, and issue remediation.

1. Summary of Pharmacovigilance (PV) Expertise and Experience
Department
startup & strategic
process
improvement:
 PV department design, job descriptions, and outsourcing strategy
 Establishment of PV internal interfaces (e.g., Clinical, Medical
Affairs, Marketing, HOER, Quality) and safety governance, call
center start up
 Adverse event collection, processing, and reporting procedures
 Process improvement and tools for case management,
PBRER/DSUR development
 Risk management plan integration
Global expansion/
product launch:
 Cross-departmental gap analysis and implementation of global
regulations including EMA GVP
 Affiliate PV department creation including allocation of PV tasks,
integration with headquarters (HQ), SOP strategy, and call center
selection and start up
PV quality system:  SOP strategy, development, and training
 Inspection readiness evaluation, preparation, and site support
 PV department, call center, and vendor audits
 CAPA root cause analysis, remediation, and management
 Compliance and quality metrics for ICSRs and periodic reports
License partner
liaison:
 Standard Safety Data Exchange Agreement (SDEA) templates
 SDEA negotiation, finalization, and implementation
 License partner management and compliance monitoring
Outsourcing:  Outsourcing strategy, RFP development, and vendor selection
 Vendor start up and on-going management
 Tools for ICSR and periodic report quality management
Clinical and post-
marketing
programs:
 Safety reporting requirements definition and standard language for
protocols, investigator-initiated research (IIR), and vendor contracts
 Safety Management Plan templates and documentation of PV
responsibilities and flow of safety information for study start-up
PV operations
project
management:
 Business requirements for database selection, customization and/or
configuration; database implementation project management
 Manage PBRER/DSUR development