PHARMACOVIGILANCE

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Vaccines, Medicines and Devices


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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.

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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.

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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.

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stay up to date with our latest news.

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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…
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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)

By Steen Ottosen  /  March 24, 2021
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

By Steen Ottosen  /  February 21, 2021
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
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Pharmacovigilance System Master File

By Steen Ottosen  /  February 20, 2021
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CONTACT US

Steen Ottosen ApS

Experts with extensive experience in Global Pharmacovigilance as well as clinical medicine are available to support pharmaceutical industry and national competent authorities

Services

  • Strategic advice for medicines authorization filings and regulator queries
  • Development and management of a pharmacovigilance function
  • Medical Monitoring
  • Medical Drug Safety Operations
  • Data cleaning and data review
  • Risk Management Plans
  • Regulatory intelligence
  • QPPV (Qualified Person for Pharmacovigilance)
  • PSMF (Pharmacovigilance System Master File)
  • Maintaining EU article 57 database, SPOR system, EVDAS and Eudravigilance database
  • Regulatory intelligence
  • Literature search
  • Regulatory compliance
  • Standard Operating Procedures
  • Signal Detection
  • Inspection Support
  • Auditing

Contact Us

Steen Ottosen ApS
Lille Graabrodrestrede 1
Odense, 5000
Denmark

E-Mail: contact@ottosen.com
Phone: +45 7734 8870
Fax: +45 7734 8818
CVR: 39620847
EAN: 5797200000767
DUNS: 30-598-6864

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