Dr. Silke Ostermann MBA, pharmacist, scientist and entrepreneur supports you as competent and reliable partner with over 15 years experience in the pharmaceutical industry and the health care sector.
Over many years, she actively managed sectors of pharmacovigilance, product development and quality management. This includes the responsibility as Qualified Person for Pharmacovigilance (Stufenplanbeauftragte) and Qualified Person for Scientific Advice (Informationsbeauftragte) in an international company.
She further worked as advisor for quality management & compliance services. In this role, she was responsible for implementation and improvement of pharmacovigilance and QM systems for national and international pharmaceutical companies.
Dr. Ostermann is very experienced in pharmacovigilance activities, QM systems and processes, auditing and ensuring compliance with legal requirements. Her experience also includes Regulatory Affairs compliance, launching activities and life cycle management in the generic and originator field.
After her pharmaceutical studies in Bonn, Germany Dr. Ostermann led the AT1 receptor antagonist voltage-clamp group at the Poliklinik in Bonn. Not only a renowned expert in research she also held lectures and managed medical student courses and examinations.
Dr. Ostermann additional got management expertise by studying MBA at the University of Applied Sciences for Economy and Management in Munich, Germany and at the Pfeiffer University, Charlotte USA with focus on process, quality and organisational development.
Dr. Ostermann is professional lecturer at TÜV Süd, BioM and member of the training comitee at megra.org.
She is member of several pharmaceutical and quality assurance associations for example German Pharmaceutical Association (DPhG), Association of Research Quality Assurance (RQA), Middle European Association for Regulatory Affairs (MEGRA), German Association for Pharmaceutical Medicine (DGPharMed) as well as contributing editor at standards.org.