Dr. Med. Dnyaneshwar Arjun Sanap

Dr. Med. 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.

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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 over its lifecycle across Phase III and IV.
Inspection success
Possesses a 100% success rate in facing major Health Authority inspections (both EU and non-EU), demonstrating robust quality and compliance.
PV system build
Pioneered the establishment of in-house global Pharmacovigilance departments, building systems from database procurement and validation to SOP creation and staff training for operational excellence.
Technology & innovation
Holds hands-on experience with AI-based safety assessment tools, leveraging technology to enhance pharmacovigilance processes.
Lifecycle management
Managed the entire pharmacovigilance lifecycle for diverse product portfolios across oncology, respiratory, cardiometabolic, and other therapeutic areas, from Phase I clinical trials to established post-marketing products.

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 numerous 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.
  • 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 topper in pharmacovigilance, clinical development, and IPR modules of his Pharma MBA program.
  • Regular participant and contributor to global pharmacovigilance conferences and training forums.

Professional Affiliations

  • Drug Information Association (DIA)
  • Research Quality Association (RQA)
  • Pharmaceutical Information and Pharmacovigilance Association (PIPA)
  • Medicines for Europe (EGA)
  • Indian Medical Association (IMA)