Your key to successfully building a pharmacovigilance ecosystem
Expert Advisory | PV Ecosystem Development | Strategic Outsourcing | Bespoke Solutions
Viginext Advisors is dedicated to supporting clients through every step of their PV system development, offering solutions that are not only compliant but also scalable and efficient. We understand the unique challenges and regulatory environments our clients face, providing expertise across all aspects of pharmacovigilance.
Portfolio
PV Ecosystem-Management
We help transform disconnected pharmacovigilance operations into synchronized safety ecosystems. Our approach integrates outsourced components into a cohesive system that maintains sponsor control while enhancing operational excellence. We design effective connections between vendors and processes to eliminate silos, optimize resources, and ensure compliance. Our expertise reduces operational friction and creates responsive safety systems that adapt to evolving regulatory requirements.
Project, Portfolio & Change Management
We provide expertise on implementing project, portfolio, and change management systems tailored to life sciences organizations. Our services include designing customized frameworks and offering guidance during transformation periods. Drawing on certified knowledge, we help prioritize initiatives and manage regulatory changes while maintaining continuity. Whether establishing a PMO or managing specific projects, we focus on building internal capabilities alongside measurable outcomes.
Clinical to Commercial Transition
We specialize in guiding biotech companies through the critical transition from clinical development to commercial operations. This shift requires evolving from controlled trial safety monitoring to comprehensive post-marketing pharmacovigilance systems. We help design scalable PV structures that accommodate expanding safety data sources, broader stakeholder engagement, and more complex regulatory reporting requirements. Our expertise ensures your organization develops appropriate safety capabilities while maintaining focus on commercial launch activities. We address the unique challenges of building compliant systems with limited resources, whether through strategic outsourcing or developing internal capabilities.
RFP, Tender & Vendor Selection
We guide life sciences organizations in selecting ideal service providers for critical functions. Our approach identifies partners who meet technical requirements and align with your organizational culture. We develop requirements specifications, manage RFP processes, and facilitate selection decisions. With deep industry insight, we help identify partners who will deliver quality and value in regulated environments.
Partner
"I have worked together with Stefan over several years and have gotten to know him as a highly motivated professional, with whom it's a pleasure to work with. Not only a cooperative and pleasant spirit, but a person with a highly analytical, sharp mind who gets to the root of problems, finds solutions and has the ability to take the team with him while striving for and implementing solutions."
Daniel Regut
Sr. Clinical Research Associate & CRA Trainer
References
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