Stefan Kaehler

Background

About Stefan Kaehler

Over 20+ years experience in pharma bussiness in different positions and departments as highly qualified professional, with a more than 30 years strong background in experimental and clinical pharmacoloy & toxicology and product development in pre- as well as post-marketing settings. Excellent interpersonal skills and the ability to communicate and present effectively. High Level of intercultural understanding. Further, over 7 years experience as qualified person for pharmacovigilance (more than 7 years as QPPV and more than 2 years as dQPPV) for high risk medicinal products during the most challenging biggest pharmacovgilance legislation change in the past centuries in EEA. Also nominated QPPV in the ARAB region (ie. Egypt, UAE, Saudi Arabia, Jordan, Kuwait, Oman). Establishment and implementation of the new PV legislation requirements as well as the PSMF (Pharmacovigilance System Master File). Extensive experience in global medicinal product risk management planning including additional risk minimisation development and implementation across the globe. Recipient of different awards for Excellence in Delivering Exceptional results as well as for Living business ethical values. Cross-departmental awards together with an affiliate in EU big 5 for the fastest implementation of an additional risk minimisation mesaure across EEA without any delay for a medicinal product Launch and Award for Outstanding Career Contribution. Experience in setting-up a manufacturer license for medicinal products in EEA as certified GMP-QP (GMP certificate issued at day of inspection), wholesaler dealer license and establishing efficiently working Compliance, Market Access, Regulatory and Drug-Safety Offices (license inspections with no obsrevation in rows). Global experience in brand protection and other international projects. More than 30+ years experience in GMP, GDP, GLP, GCP and GVP inspections.