PV - Set - Go . . .
Establishing a future-ready PV ecosystem
FUTURE-READY PATIENT SAFETY UTILIZING A BLEND OF PEOPLE, PROCESS, AND TECHNOLOGY TO DELIVER THE FULL SPECTRUM OF PHARMACOVIGILANCE
At Navitas Life Sciences our experienced Pharmacovigilance (PV) Consulting team aid organizations in building and implementing global future-ready PV systems. Backed by insights from our industry-leading PV networks, pvnet®, pvconnect®, pvtech®, and pvindia®, we empower our clients to make informed decisions on how to build a future-ready PV organization and achieve strategic objectives faster by incorporating our proven best practices.
We understand the difficulties faced by emerging pharmaceutical companies as they move towards post-marketing, and have worked to simplify the most common PV Service requests, budget, and timeline into our PV - Set - Go offering as we work to deliver the fundamentals of implementing a PV system in a cost effective manner.
ARE YOU LOOKING TO BUILD YOUR PHARMACOVIGILANCE SYSTEM FROM SCRATCH?
When should we start implementing our PV System?
- Navigating the regulatory requirements where the product(s) will be marketed; global authorities require a trained network of Qualified Persons who can work with local and regional regulators
- Headcount, skills, and capabilities needed for core PV capabilities and how to source to avoid risk of non-compliance
- Harmonized Standard Operating Procedures (SOPs) and process - establishing written documentation of procedures to create efficiency and ensure that people, process, and technology are aligned
- Marketing Authorization Holders (MAHs) must have a detailed plan and clear understanding of how they will receive, aggregate, and report safety information. A Pharmacovigilance System Master File (PSMF) may also be required by certain markets
- Effective selection of tools, including the right safety database for your organization, to complement workflows
- Developing an inspection-ready Quality Management System (QMS)
PV - Set - Go delivers:
PV Readiness Assessment
Providing a clear roadmap for a future-ready, fit-for-purpose PV system
- A comprehensive assessment to understand your current PV system compliance gaps
- Recommendation(s) for fit-for-purpose improvements that ensure regulatory requirements are met
- Strategic roadmap to achieving PV business objectives
Tailored PV Operating Model
Delivering an optimized organization structure and governance model
- An optimal resourcing model to meet the capability requirements required to support core PV operations
- Identification of opportunities and potential partners for outsourcing and offshoring non-core transactional activities
- Define, source, and establish a trusted network of QPPVs to support global requirements
Technology Assessment and Roadmap
Helping your organization achieve more by leveraging NextGen technology solutions and systems
- Navigating the vendor landscape with an in-depth evaluation of multi-tenant vs. single tenant safety database options
- Benchmarking current technology against industry best practice(s) and the market landscape
- Providing a business case for IT investment
Quality Management System Development
Ensuring Regulatory Compliance through a harmonized Standard Operating Procedure (SOP) framework
- Establishing SOP governance to drive strategic alignment with business, content owner, cross-functional business, and technology
- Developing a simplified document framework and aligned structure
- Authoring and updating SOPs