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.
- E2E Pharmacovigilance Processes
- PV Ecosystem Development
- Automation & AI
- Safety Database implementation
- Outsourcing Strategy
Project & Change Management
Niamh McArdle
Dr. Example Name, MD, PhD, MBA
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.
- Project management and change management
- Outsourcing strategy
- PV Auditor
- Safety Science (Signal Analysis, risk management, periodic reports)
- PSMF creation and management
- Vendor and Partner 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.
- 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
Dr. Example Name, MD, PhD, MBA
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.
- Pharmacovigilance Pre-Approval Setup
- E2E Pharmacovigilance and Labelling Processes
- Medical and Affiliate Governance
- Outsourcing Strategy
- Project & Change Management
- PV Technology Validated Implementation
Dani Lechner
Dr. Example Name, MD, PhD, MBA
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
