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
Sanjay Motivaras
MRPharmS, Hon FPIPA, MRQA Sanjay Motivaras is an established Independent Pharmacovigilance Auditor and Consultant with over 19 years of experience in global pharmacovigilance, quality assurance, and regulatory compliance. A registered pharmacist and Qualified Person for Pharmacovigilance (QPPV), Sanjay has performed more than 400 audits across headquarters, affiliates, license partners, and vendors worldwide. He has successfully implemented global PV Quality Management Systems, developed and reviewed SOPs, authored regulatory communications, and coached companies in inspection readiness. Sanjay’s expertise spans root cause analysis, risk assessment, and the integration of compliance processes across complex organisational structures. Sanjay holds a Master of Pharmacy (Hons) from De Montfort University and is a Fellow and Honorary Member of the Pharmaceutical Information and Pharmacovigilance Association (PIPA), where he has served as Treasurer and Executive Committee Member. He is also an elected committee member of the Research Quality Association (RQA) Pharmacovigilance Committee and a tutor for RQA’s Pharmacovigilance Auditor course. Throughout his career, Sanjay has held key roles such as Director of Audit PV Limited, Deputy QPPV for Europe, Quality Assurance Manager Pharmacovigilance at Grünenthal GmbH, and Senior PV Scientist at Ipsen Biopharm. Areas of special interest and expertise: Pharmacovigilance Auditing (Human & Animal Health) Audit & Inspection Readiness Preparation PV Quality Management Systems development & integration Gap Analysis & Impact Assessment against EU GVP & global PV legislation Regulatory Communications with Competent Authorities Vendor Assessment & Internal Capability Building · Due Diligence Support during M&As Mentoring & Training
Julia Daake
Julia has 15 years of extensive recruiting experience in the roles as Interim Recruitment Manager/ Recruiting Expert for roles in Pharmacovigilance and Regulatory Affairs. She has worked as an external and internal Recruiting Expert; from small to big pharmaceutical and biotechnology companies; supporting national and international teams to grow and evolve. Her goal is to hunt exceptional diverse talent and add value to the business while optimizing time-to-hire. Areas of special interest and expertise: Business Development and Customer Engagement Pharmacovigilance Advisory Interim Recruiting Services Talent Acquisition Support Strategic HR Advisory