We have a passion for helping emerging and established biopharma organizations address a multitude of business challenges including full Pharmacovigilance (PV) functional builds and transformations.
This includes the setup and management of pharmacovigilance systems, governance structure, supporting SOPs, quality and compliance enhancements, process and re-engineering improvements within clinical and postmarketing-stage biotech and pharmaceutical environments. The results yield an operational and inspection-ready PV function.
We have provided consultative services to top US and international management consulting firms and Wall Street analysts.
Successful projects kickoff with a comprehensive PV Diagnostic Assessment and Checklist beginning with a review of Pharmacovigilance Strategies, and culminating with an analysis of risk management activities and an assessment of compliance with worldwide regulations. The diagnostic results are then compared against industry best practices, global regulations and current guidelines. An organized roadmap is then created to remediate or mitigate identified gaps.
Changing or building new organizations, optimizing processes and streamlining operations are never for the faint of heart. Combine that with the most heavily regulated industry on the planet and the tasks appear insurmountable, even to the savviest executive teams. We are experienced executives who have this expertise and can help you through the maze of project and change management onward toward success.
Recent Work Snapshot
- Comprehensive PV Diagnostic Assessments and PV Functional Builds
- Global Regulatory and Quality Expertise
- Operational and Inspection-Readiness Preparations
- SOP Prioritization and Development
- Organizational and Governance Structure Design and Implementation
- Worldwide Drug Safety Office Strategic Planning, Launch & On-going Risk Management
- Setup and maintenance of the Pharmacovigilance System Master File (PSMF)
- PV Quality & Compliance enhancements including PSPs, REMS/RMP & Consumer Engagement
- Root Cause Analysis & CAPA Management
- Safety Vendor Management and Oversight
- Resource Planning including Business Process Off-Shoring/Outsourcing (BPO) & Insourcing
- Relevant Job Descriptions and Charter Development
- SDEA/PV Agreements
- Decision Support Tools, Dashboard KPIs
With whom you entrust your transformation will be an important part of your framework for success. Our reputation and experience making this journey efficient and even enjoyable, sets us miles apart from others. We would jump at the opportunity to work with you on your project.