Your key to successfully building a pharmacovigilance ecosystem
Expert Advisory | PV Ecosystem Development | Strategic Outsourcing | Bespoke Solutions
Viginext Advisors supports small and medium-sized biotech and pharmaceutical companies in developing effective PV ecosystem solutions. We provide customized consulting for companies that need to meet complex regulatory requirements with limited resources – for example, during the transition from clinical to commercial phase or when optimizing existing PV systems. With extensive industry experience, we develop PV ecosystem approaches that are not only compliant but also cost-efficient and scalable to grow with your company.
Portfolio
PV Ecosystem-Management
We transform fragmented pharmacovigilance processes into a harmonious safety ecosystem specifically designed for small and medium-sized pharma and biotech companies. Our approach integrates all outsourced components into a coherent system where you, as the sponsor, maintain complete control while benefiting from optimized, resource-efficient processes. With our expertise in EU pharmacovigilance structures, we eliminate silos between internal teams and external service providers, create transparent interfaces, and ensure continuous compliance - even with limited internal resources. Through strategic integration of service providers, processes, and technologies, we reduce operational friction and develop an adaptable safety system that keeps pace with your company's growth and evolving regulatory requirements. The result: A tailored PV system that minimizes compliance risks, optimizes costs, and gives you the confidence to focus on your core business activities.
Project, Portfolio & Change Management
We support small and medium-sized life sciences companies in implementing customized project, portfolio, and change management systems specifically tailored to limited resources and regulatory requirements. Our approach combines methodological expertise with practical implementation skills – from designing individual frameworks to actively guiding you through critical transformation phases. With certified expertise in leading PM methodologies and years of industry experience, we help you strategically prioritize projects and efficiently implement regulatory changes without disrupting ongoing operations. We consider the unique challenges of growing companies and focus on pragmatic solutions that deliver quickly measurable results. Whether establishing a lean PMO, managing key projects, or orchestrating complex change processes – we are committed not only to achieving short-term success but also to sustainably strengthening your internal capabilities, enabling you to independently master future challenges.
From Development to Commercialization
We guide small and medium-sized pharmaceutical and biotech companies through the challenging transition from clinical development to the post-marketing phase. This critical transformation requires evolving from structured safety monitoring in clinical trials to a comprehensive, regulatory-compliant pharmacovigilance system for the market phase. With our specialized expertise, we design scalable PV structures that keep pace with growing data sources, more diverse stakeholders, and increasingly complex reporting obligations. We address the specific challenges faced by companies with limited resources and develop tailored solutions that are both compliant and economically viable. We ensure your company builds the necessary safety competencies while you focus on critical aspects of market launch. Whether through strategic outsourcing, implementation of efficient processes, or targeted development of internal capabilities – we offer proven solutions that enable a smooth transition to the commercial phase while establishing a solid foundation for future growth.
Pharmacovigilance Vendor Selection & RFP Management
We support small and medium-sized life sciences companies in the strategic selection of suitable pharmacovigilance service providers. Our structured approach identifies PV partners who not only meet technical and regulatory requirements but also fit your corporate culture and understand the unique needs of growing organizations. With deep industry knowledge and extensive experience in PV outsourcing, we develop precise requirement profiles that consider your specific safety system needs, from case processing and aggregate reporting to signal management and database administration. We manage the entire RFP process – from creating customized vendor questionnaires to detailed evaluation of proposals – and guide your decision-making with objective analyses and recommendations. Particularly valuable for companies with limited internal resources: We help you find the right balance between outsourced PV services and internal oversight capabilities, ensuring that your vendor relationships are cost-efficient, compliant, and sustainable as your product portfolio grows. This enables you to find pharmacovigilance partners who reliably deliver quality in regulated environments and create genuine value for your safety system.
Stefan Brüning
Dipl.-Biol., MBA, PMP®, IMCM®, MRQA
Stefan Brüning is a Life Sciences expert with over 15 years of specialized experience in pharmacovigilance (PV), healthcare, pharmaceuticals, and business consulting .
As the founder of Viginext Advisors GmbH (formerly Brüning Consulting), he has established a boutique consulting firm dedicated to developing tailored pharmacovigilance systems for pharmaceutical and biotech companies, with particular expertise in supporting organizations transitioning from clinical research to post-marketing responsibilities .
With professional experience at organizations including Horizon Therapeutics (now Amgen), PRA Health Sciences (now ICON), and Navitas Life Sciences (formerly WCI), Stefan brings comprehensive understanding of the challenges faced by emerging life sciences firms in establishing effective pharmacovigilance systems. His expertise spans the critical transition from GCP-focus to GVP environments, helping clients navigate complex regulatory landscapes while maintaining strategic control of their safety operations .
Stefan holds a Master’s degree (Diplom-Biologe) in Molecular Biology from RWTH Aachen University and an MBA from IU International University . His professional credentials include certifications as a Project Management Professional (PMP®), International Multidisciplinary Change Manager (IMCM®), Professional Scrum Master, and Professional Scrum Product Owner.
Areas of special interest and expertise:
- E2E Pharmacovigilance Processes
- PV Ecosystem Development
- Automation & AI
- Safety Database implementation
- Outsourcing Strategy
- Project & Change Management
Janine Gavin
BA Combined Hons, Advanced Dipl. HonPIPA, MRQA
Janine Gavin is an established Independent Life Science Consultant with over 15 years of experience specialising in post-Marketing Pharmacovigilance, Medical Information, and strategic advisory roles.
Janine has successfully implemented effective Pharmacovigilance & Medical Information Systems, developed audits and inspections storyboards, and merged multiple Pharmacovigilance systems. Janine’s domain expertise includes process optimization, cross-functional alignment, and project management in critical PV areas.
Janine holds a BA (Combined) Honours in Social Sciences, an Advanced Diploma in Psychotherapy, and a Diploma in Anatomy & Physiology. Janine has also completed various Management Forum Courses and an RQA Course on Practical Pharmacovigilance Auditing.
Throughout Janine’s career, she has held key roles such as Pharmacovigilance Partnering Lead, Manager Consumer Services & UK NCPV, and Vice-President – PIPA, among others.
Areas of special interest and expertise:
- Pharmacovigilance & Medical Information Systems integration
- Audit & Inspection Readiness Preparation
- Process optimization in critical PV areas
- Cross-Functional Process alignment with Quality Management
- Project Management in PV areas
- Gap Analysis & Impact Assessment
- Vendor assessment and internal capability building
- SOP Process mapping and integration
- Due Diligence support during M&As
Jeff Ho
BSc
Jeff is a Life Science consultant with a unique blend of experience in R&D with a specialisation in Pharmacovigilance backed by deep technology knowhow. His 25+ years of experience has come from working with over 40 large and mid-size pharmaceutical companies.
He has a consistent track-record of supporting Senior/Executive Managers in delivering global change programs across the entire product lifecycle. Programs have involved multi-functional engagement with Clinical, Pharmacovigilance, Regulatory Affairs, and Medical Affairs.
Key business benefits have been consistently delivered by establishing clear governance, leveraging automation, and embedding process improvements while ensuring GxP compliance.
Jeff holds a B.S. in Mathematics/Computer Science and Psychology from Carnegie Mellon University with a focus on cognitive psychology and artificial intelligence.
Areas of special interest and expertise:
- Pharmacovigilance Pre-Approval Setup
- E2E Pharmacovigilance and Labelling Processes
- Medical and Affiliate Governance
- Outsourcing Strategy
- Project & Change Management
- PV Technology Validated Implementation
Niamh McArdle
BSc
Niamh is a highly proficient Pharmacovigilance (PV) professional with 19 years’ experience in the industry.
Niamh’s combined expertise in PV science and operations enables her to deliver a comprehensive, efficient, and compliant approach to pharmacovigilance. Her scientific insight ensures accurate safety data interpretation, while her operational skills drive effective implementation through streamlined systems and regulatory adherence—ultimately enhancing quality, efficiency, and value for clients.
Since 2024, Niamh has specialized in pharmacovigilance consulting, supporting organizations with SOP development, storyboard and playbook creation, PSMF preparation, signal analysis, RFP management and bid defenses, as well as conducting audits.
Before transitioning to consulting, she held leadership roles in several pharmaceutical companies, bringing a wealth of hands-on industry experience.
Niamh holds a BSc in Biochemistry and a postgraduate diploma in Public Relations and has completed numerous professional courses in project management, pharmacovigilance agreements (PVAs) and Pharmacovigilance auditing.
Areas of special interest and expertise:
- Project- and Change Management
- Outsourcing strategy
- PV Auditor
- Safety Science
- PSMF creation and management
- Vendor and Partner management
Dani Lechner
Dani is a seasoned Business Development Director with over a decade of experience bridging clinical research operations and commercial growth in the pharmaceutical and biotech industries.
With a strong track record of supporting the development of innovative therapies by combining deep expertise in clinical trial operations, supply chain optimization, and strategic partnership development.
Since transitioning from clinical research roles to business development leadership, Dani has focused on delivering tailored solutions in clinical trial supplies, comparator sourcing, and stakeholder collaboration, helping sponsors and CROs streamline complex trial logistics and drive successful outcomes.
Fluent in English, French, and German, Dani leverages her operational and commercial insights to advance science and health globally.
- clinical trial operations
- clinical trial supplies
- comparator sourcing
- supply chain optimization
- strategic partnerships & revenue growth
Jan Mueller
Jan Mueller is a seasoned business development professional with an industry specialization in life sciences. He holds a Master of Arts in Political Science and most recently achieved Certificates of Advanced Studies (CAS) in Business Analysis and Management in Life Sciences. Since 2025, Jan is working as a freelancer and a start-up entrepreneur.
- Strategic Vendor Management
- Vendor Selection
- RFP Management
- PMO Support
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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