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Dr. Silke Ostermann MBA, pharmacist and scientist ywith over 20 years experience in the pharmaceutical industry and the health care sector leads the company.
Over many years, she actively managed sectors of pharmacovigilance, product development and quality management. This includes the responsibility as Qualified Person for Pharmacovigilance (QPPV and 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. Based on this she took over the role as Responisble Person Whole sale and accompanies wholesalers and pharmaceuticals companies in their processes.

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 committee 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.

CSO Services

We provide reliable Pharmacovigilance services, professional Medical Affairs support and succesful Quality Management and GDP Consulting <link en services our-services externallink>>>