Mark Waring

Drug Safety, Pharmacovigilance

CONELIS expert Mark Waring

Mark Waring Pharmacovigilance Services


German, English

Services offered worldwide

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  • Strategic advice and hands-on support for pharmacovigilance and safety risk management planning during clinical development, before regulatory submission and for marketed products
  • Pharmacoepidemiological study design
  • Preparation of periodic safety reports for regulatory submission (Annual Safety Reports, Periodic Safety Update Reports)
  • Ad hoc safety signal evaluation
  • Literature review for safety topics
  • Training in pharmacovigilance
  • Evaluation of safety data in the context of due diligence activities

About Me

Dr. Waring is a licensed physician with clinical experience in internal medicine and a research background in endocrinology and neuropharmacology. He also holds a Master degree in epidemiology. He has more than ten years of industry and consulting experience in clinical drug safety and post-marketing pharmacovigilance, pharmacoepidemiology and pharmaceutical safety risk management. Prior to founding Mark Waring Pharmacovigilance Services in April 2007, he held positions in the drug safety functions of two large, globally operating pharmaceutical companies.

Dr. Waring has led or supported the design and preparation of numerous risk management plans, including plans deployed for major products in an environment of significant public interest and regulatory scrutiny. Likewise, he has authored numerous periodic reports in various formats for a wide array of medicinal products, ranging from pragmatic reports for products with low case loads to major documents evaluting tens of thousands of individual ADRs.

Dr. Waring has an immaculate track record of on-time delivery of high quality documents meeting regulatory expectations. His medical expertise and operational experience is complemented by a thorough understanding of global and EU pharmacovigilance system requirements. He has led or supported pharmacovigilance system quality improvement initiatives in several companies. His particular areas of pharmaceutical expertise include drug hepatotoxicity and the safety of biological therapeutics.


Licensed physician, Dr. med.
Master of Science (Epidemiology)

Areas of Expertise:

Drug Safety, Pharmacovigilance