About Steen Ottosen ApS

Global Drug Safety and Pharmacovigilance Oversight
EU Qualified Person for Pharmacovigilance

The QPPV function has become essential for any international pharmaceutical company. More than 10 years of experience with the QPPV role and the PV Master File allows us to support your organisation from developing the filing to post market support with all QPPV related services and oversight .

Qualified Person for Pharmacovigilance

The Qualified Person for Pharmacovigilance is an individual personally responsible for a Pharmaceutical company/Marketing Authorisation Holders …..

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Pharmacovigilance System Master File

The regulations for the European Union has a requirement for a Marketing Authorisation holder to maintain a document with all information relevant for the safety of a marketed …..

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Standard Operating Procedures

The drug safety/pharmacovigilance function of a Pharmaceutical companies are required to keep a quality management system in place. A central part for the quality management system is written policies, procedures and detailed work instructions as well as documentation for review and training in these instructions by all relevant staff in the company, suppliers, contractors and partners. 

Signal Detection

Data received from non interventional studies, clinical trials and post market experiences are monitored to ensure timely identification of new potential safety issues with your products. Fast identification and verification of signals is essential to keep patients and the product safe and for you to know before the regulatory agencies start asking the critical questions.

Living it up in Copenhagen, Denmark.