Table 2.

Proactive pharmacovigilance best practices and key processes or activities in the areas of organizational alignment, operations management, data management, and risk management

Organizational alignment	Operations management	Data management	Risk management
Align operational activities across different functional groups and departments	Implement process-driven standard operating procedures, work instructions, and training materials	Design science-driven, site workflow-focused, and standard-based case report forms for post-marketing studies	Develop an objective, data-driven, team-oriented approach to risk monitoring and evaluation
Implement well-defined decision-making models, escalation processes, and communication channels	Designate a pharmacovigilance operating model and business process owner (Debatably, this may be under “Risk management”)	Implement data mining techniques to bolster safety analytics, reporting, and investigation	Determine the pharmacovigilance workload and sufficiently resource the required effort
Incorporate continuous improvement activities and standardized risk communication plans (Need buy-in from “Risk management”)	Ensure that appropriate process and organizational checks and balances are in place to limit bias and manage regulatory risk	Develop standard edit check specifications for AEs and adjudication process forms	Implement workflow management technology to ensure appropriate transparency and accessibility of safety information
Retain key pharmacovigilance personnel with cross-disciplinary expertise and skill sets – This will involve all others as well	Create dashboard to summarize timely awareness of safety risks across the portfolio and timely execution of safety risk minimization activities	Develop standard based metrics reports and data management reports	Select a vendor that best matches the pharmacovigilance operating model, business process and vendor/system selection criteria (Need buy-in from DM)
Examine corporate IT platform and have vision for a long term pharmacovigilance strategy	Manage and provide oversight to CROs recruited for portion or all of a clinical study	Lead integration efforts in building interoperability among CDMS, CTMS, Safety System, coding application	Develop risk management action plans based on pre-established risk scoring mitigation processes
Re-organize functional groups as needed		May be the owner of coding application and data migration Provide trainings to other functional groups	Define and provide alert or signal threshold – This will involve others as well

Abbreviations: AE, adverse event; CRO, clinical research organization; DM, data management; CDMS, clinical data management system; CTMS, clinical trial management system.