Achieve greater levels of quality and efficiency in your pharmacovigilance (PV) signal management with accurate, meaningful outputs that result in zero FDA inspection findings.
For over six years, UBC has served as a functional service provider (FSP) for a leading pharmaceutical company. Our dedicated team of PV signal management experts have managed signal detection, validation, and assessment for approximately 100+ products within the neuro-rheumo/immuno sectors.
Key Challenges in PV Signal Management
Our client faced several complex challenges in executing their signal management strategy:
- Workload Variability: Managing variable workloads triggered by safety signals and the requirements of periodic safety reports (PSRs), including a high volume of products with varying regulatory needs.
- Operational Quality and Effectiveness: Maintaining efficiency while navigating diverse PV tasks, such as semi-quantitative monthly & quarterly analyses of the safety database, datamining in FDA’s Adverse Event Reporting System (FAERS) with Oracle Empirica, benefit-risk evaluations, and crafting risk management plans (RMPs).
- Regulatory Compliance: Guaranteeing the prompt identification and communication of potential safety signals to maintain compliance with global health authorities, including the FDA and EMA.
- Complex Communication: Effectively communicating with multiple client stakeholders, including local pharmacovigilance officers (LPOs) and representatives from various departments (medical, clinical, PV), who often have different interpretations of requirements and data.
UBC's Innovative PV Solution and Results
UBC’s solution encompassed a tailored approach to meet each challenge:
- Scalable Team Dynamics: Employing a strategic scalability model that enhances the dedicated support team with expert scientists and physicians, ensuring adaptability to workload fluctuations.
- High-Quality and Efficient Processes: Leveraging functional service provision (FSP) safety scientists and safety physicians enables specialization in product expertise and fosters seamless collaboration with the client’s safety team.
- Accessible and Intuitive Technology: Demonstrating flexibility by proficiently adapting to the client’s tools, such as Oracle Empirica for datamining, and utilizing Veeva Vault for standardized and auditable document management and periodic safety update reports (PSURs) writing.
- Specialized Talent Deployment: Deploying highly trained safety scientists and safety physicians with extensive PV experience is paramount for executing multifaceted PV tasks—from signal detection and regulatory compliance to risk management—with accuracy and efficiency.
Significant Results
UBC’s integrated signal management and unmatched patient safety and regulatory adherence resulted in significant outcomes:
Zero findings from FDA inspections regarding the outsourcing model or deliverables for 100+ products.
Significant improvement in signal detection efficiency and reduction in response times to over 90 health authority requests.
Enhanced quality and compliance across all aspects, from PV signal detection to Dear Healthcare Provider (DHCP) letter writing.
A 20% increase in client satisfaction scores for operational effectiveness and relationship quality.
Master PV Signal Management: Achieve Zero FDA Findings
See how UBC’s expertise in PV, risk management, and safety signal detection can strengthen your program. UBC has helped more than 70 companies by implementing and managing over 78 PV programs in the last five years.
