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