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Global Pharmacovigilance Readiness Checklist

An extensive PV overview to ensure compliance with patient safety and regulatory requirements.

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UBC Global Pharmacovigilance Readiness Checklist, an extensive PV overview for patient safety and regulatory compliance.
  • 3 min read

UBC’s pharmacovigilance (PV) experts understand the rapidly evolving safety and regulatory landscape, and have developed this PV readiness checklist to help you take a comprehensive, early approach to patient safety within the drug development and commercialization process. We outline flexible solutions in all categories of PV to make it easier for you to maintain patient safety and ensure high regulatory compliance.

Comprehensive Checklist of Patient Safety Responsibilities

Our checklist will help you assess these key areas and safety elements critical to your product success:

  • Enhanced Operational Delivery
  • Pharmacovigilance Signal Management
  • Global Case Processing
  • Safety Regulatory Intelligence
  • Regulatory Reporting
  • Comprehensive Safety Systems
  • Data Migration
  • Literature Review
  • EU Pharmacovigilance

Enhanced Operational Delivery & Safety Products

To streamline and simplify data mining and analytics, UBC provides key tools and operational plans:

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Information Technology

Visually Impactful Tableau® Analytics Dashboards, UBC Signal Management Software

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Automation

Case Processing Automation (Machine Learning, AI, OCR)

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Project Plans

Operational Plans (e.g., Adverse Event Reporting Plan, Signal Detection Plan), Quality Agreement, and Training Plan

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Medical Information Call Center

Product Quality Complaints, Adverse Event Intake, Development of Standard Response Letters (SRL)

Control Your Patient Safety Strategy with UBC's Expert Checklist

As a leader in pharmacovigilance, UBC combines deep clinical expertise with innovative technologies to empower safety surveillance from initial clinical development to commercialization. Download the Global Pharmacovigilance Readiness Checklist and begin your safety and risk management assessment.

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Bekki Bracken Brown

President & Chief Executive Officer

Bekki Bracken Brown serves as the President and CEO of UBC, guiding the company’s mission and values, including the improvement of access for patients to receive better outcomes. She oversees all aspects of UBC, such as operations, business growth strategy, sales and marketing, and acquisition support.

With over 20 years of industry experience, Ms. Brown brings knowledge from a successful career in senior management from her tenure at Quintiles, INC Research, and, most recently, with Syneos Health. She’s been a member of the North Carolina BIO Board of Directors since 2019. She is also a member of the Healthcare Businesswomen’s Association — Southeast Chapter and CHIEF, an organization that supports women executive leaders. Ms. Brown earned her bachelor’s degree at Duke University.