PHARMACOVIGILANCE

How to Trust
Vaccines, Medicines and Devices

Let us introduce ourselves

ABOUT STEEN OTTOSEN APS

Steen Ottosen ApS is working with pharmaceutical and biotech companies of all sizes from large pharmaceuticals to micro startups to shape their pharmacovigilance (drug safety) function and for larger pharmaceutical companies to streamline their operation and constantly adapt to the complex global regulatory framework.

OUR SERVICES

GLOBAL PHARMACOVIGILANCE 

We assist small to large pharmaceutical companies all over the world keeping medicines, vaccines and devices safe for the users and the company in compliance with regional and national regulations. Our services include medical reviews of adverse events, medical monitoring of clinical trials, signal and risk management , PSUR, DSUR, RMP, EVDAS, Eudract, SPOR etc and communication with national competent authorities. We are fully engaged in all aspects of pharmacovigilance right from full management of an internal pharmacovigilance department to individual and specialized tasks.  Having expert medical staff with many years of experience in pharmacovigilance in both US and EU we are also providing support with all aspects of Qualified Person for PharmacoVigilance responsibilities at EU level and at individual member state level.

Our Shop

Here you can find SOP templates, document templates, presentations and guides that will help you get organized and personalized support is available if you should need that.

Literature Search

In Collaboration with Europe PMC (PubMed + non-US articles) we have developed a free access system to search in one of the biggest clinical scientific databases in the world designed for pharmacovigilance related searches. In addition there is free access to a large number of full text articles.

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LATEST NEWS

Updated requirements for pharmacovigilance contact person at national level in EU (LCPPV)

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It is difficult to get clear information about the requirements…
Updated requirements for pharmacovigilance contact person at national level in EU (LCPPV)
EMA regulatory

Updated requirements for pharmacovigilance contact person at national level in EU (LCPPV)

It is difficult to get clear information about the requirements for local contact persons for pharmacovigilance in the EU as...
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Targeted Adverse Event Questionnaires
Targeted AESI Pharmacovigilance Questionnaires

Targeted Adverse Event Questionnaires

Normally adverse events are reported from clinical trials and from market sources containing the information the reporter consider essential, but...
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Pharmacovigilance System Master File
Product

Pharmacovigilance System Master File

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