The pharmacovigilance (PV) team at a large, global biopharma company faced a challenging operational environment. Plagued with a host of disconnected systems, their day-to-day operation weighed them down with a stream of recurring inefficiencies, inaccuracies, and added oversight costs.
By implementing a set of strategic process improvements and then performing a data quality alignment, the biopharma company’s PV leadership team was able to break the cycle and transform their operations.
Partnering with HighPoint, they achieved this transformation with support from industry experts. They leveraged HighPoint’s senior team of pharmacovigilance thought leaders and subject matter experts spanning business operations, technology, regulatory reporting, validation, and compliance.
HighPoint provided a thorough analysis of the PV team’s operations, enabling identification of the optimal path forward out of their consistency challenges.
By listening to the client from the perspective of HighPoint’s industry veterans, it was determined that:
- The PV business team operated as many independent operational teams with unique perspectives
- Many disparate sources of knowledge and documentation presented compliance and auditability issues
- Disconnected processes and procedures were leading to quality issues and regulatory risk
- A consistent operating model was necessary, which could be achieved through harmonization
Through a series of detailed “Analysis and Design” workshop consultations, the following key areas were addressed:
- Global work process standardization: Unification of business processes into a consistent workflow and governance model
- Documentation and quality: Updates of process documentation, work instructions, job aids, SOPs. Established a redesigned repository and file structure for storing and locating documents with significant improvements in standard naming conventions, providing overall organization and structure
- Training and skills development: Improvements to training documentation and categorization and prioritization of assigned training curriculums
- Systems and integration enhancements: Review of safety systems, reports, and integration points to reflect optimized global work processes
- Data quality improvements: Review of safety data quality and cleansing activities to rationalize for consistency
- KPIs and metrics: Development of reports to track process efficiencies, areas for improvement, application of resources
- Strategic vendor management: Engagement with third parties to manage compliance
- Audit readiness and compliance management: Establishment of processes, procedures, and personnel to maintain effective readiness for regulatory engagements
To learn more about how you can transform your business operations to reduce costs and risk and create an efficient path forward, please reach out to Seth Warhaftig or Stephen Parker for Operational Excellence and Audit Readiness expertise.