Our Leadership
Dr. Dnyaneshwar Arjun Sanap
MBA - Strategic EU/QPPV & Global Pharmacovigilance Leader
A highly accomplished physician and pharmacovigilance executive with nearly two decades of experience ensuring drug safety from clinical development through post-marketing. Dr. Sanap has served as the legally accountable EU and UK Qualified Person for Pharmacovigilance (QPPV) for multiple organizations, demonstrating a proven track record of building robust PV systems, successfully navigating major regulatory inspections, leading cross-functional international teams, and auditing global PV systems for leading pharmaceutical companies. He combines deep clinical insight with strategic business acumen to safeguard patient health and ensure regulatory compliance worldwide.
Professional Leadership
Director of Medical Safety Science, Ascendis Pharma Endocrinology GmbH, Germany
EU/UK QPPV & Regional Head Global Pharmacovigilance (Director), Glenmark Arzneimittel GmbH, Germany
Global Risk Management Physician (Associate Director), Boehringer Ingelheim International GmbH, Germany
Senior Manager, EU QPPV, Sun Pharmaceutical Industries Europe BV / Taro Pharmaceuticals (UK) Ltd.
Founder & Freelance Consultant, DSPV Consultancy, Germany
Key Areas of Expertise
EU & UK QPPV Services & Accountability
End-to-End Pharmacovigilance System Management
Signal Detection, Risk Management & Benefit-Risk Assessment (RMP, aRMMs)
PV System Audits, Inspections, and CAPA Management
Aggregate Report Preparation (PSURs, PBRERs, DSURs)
Medical Monitoring for Clinical Trials
Health Authority Interaction & Strategy (EMA, FDA, MHRA, Health Canada, BfArM)
Establishment of In-house Global PV Departments
Pharmacovigilance Agreement (SDEA) Management
Team Leadership & Stakeholder Management
AI-Enhanced Safety Surveillance
Career Highlights & Impact
Regulatory Accountability: Served as the legally accountable EU and UK QPPV for multiple organizations, ensuring global compliance with evolving regulations.
Strategic Safety Oversight: Provided strategic safety oversight for a blockbuster cardiovascular product at Boehringer Ingelheim, managing its risk profile across Phase III and IV lifecycle stages.
Inspection Success: Achieved a 100% success rate in major Health Authority inspections (EU and non-EU), demonstrating strong quality and compliance systems.
PV System Build: Established in-house global pharmacovigilance departments, from database procurement and validation to SOP development and team training.
Technology & Innovation: Hands-on experience with AI-based safety assessment tools to enhance pharmacovigilance efficiency and accuracy.
Lifecycle Management: Managed end-to-end pharmacovigilance across oncology, respiratory, cardiometabolic, and other therapeutic areas from Phase I trials to post-marketing.
Board & Advisory Roles
Freelance Consultant, providing expert QPPV, auditing, and strategic PV services to the pharmaceutical industry.
Education & Professional Development
Master of Pharma Business Administration (MBA), Goethe Business School, Frankfurt, Germany
Master of Science (Pharmaceutical Medicine), Maharashtra University of Health Sciences, Nasik, India
Bachelor of Medicine and Bachelor of Surgery (MBBS), Maharashtra University of Health Sciences, Nasik, India
Qualified PVQA Auditor with advanced certifications in Signal Management, Risk Minimization, and Pharmacovigilance Auditing
Awards, Recognition & Scholarship
Co-author of peer-reviewed publications in internationally recognized journals, focusing on health-related quality of life in patients with epilepsy.
Recipient of multiple industry awards for excellence, including the Numero-Uno Award and Star of the Month for outstanding performance in aggregate reporting and medical review.
Nominated for the President’s Excellence Award and Individual Excellence Awards at Glenmark for superior performance and strategic leadership.
Recognized as a top performer during academic pursuits, including securing top ranks in pharmacovigilance, clinical development, and IPR modules in the Pharma MBA program.
Active participant and contributor to global pharmacovigilance conferences and professional training forums.
Professional Affiliations
Drug Information Association (DIA)
Research Quality Association (RQA)
Pharmaceutical Information and Pharmacovigilance Association (PIPA)
Indian Medical Association (IMA)
