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Safety Competence

Regulators require competence (from the Latin competere: to be able to do something, to come together) in all aspects of Pharmacovigilance from Marketing Authorisation Holders. Patients expect it as a given.
Pharmacovigilance GmbH & Co. KG offers more than 50 years of combined Safety Competence, in addition to medical qualifications.

This ranges from Drug Safety Monitoring Boards, to Risk Management Plans, Pharmacovigilance systems, inspections, data entry and assessment, periodic reports, signal detection, recalls etc. More …

Risk Assessment

Though often forgotten, it is the base of effective action in risk management: Risk can only be dealt with appropriately if benefit is noted and correlated to it.

Risk assessment is situated right at the cross section between science and probability, liability and law, communication and ethics, whether in an individual case, a PSUR, a benefit risk assessment, or a Risk Management Plan.

Sometimes it is an art, sometimes politics. More …


trainingIt is one thing being able to do something. However, being able to convey something is different.
can do both and doesn´t only teach contents of guidelines and laws, but also shows how to translate these into your daily work in a meaningful way.

We have experience in all aspects of Pharmacovigilance and can clearly convey our knowledge. This may be a basic course for PV beginners or expert knowledge for advanced levels. Choose the format most conducive to your needs: Seminars, workshops, role plays, case scenarios, in-house training or training on the job. More …

Consulting with Heart

Cross your heart: What do you really expect from a good ‘Consultant’?

The way we understand our role is that we put ourselves in your shoes. We don´t just take care of assignments, we take responsibility for them. We are involved when project goals have to be reached or timelines have to be met. This means that we stick to agreements and objectives, even when the going gets tough and time gets short.

However, there is something in addition to being oriented toward your interests. We do have a heart for patients: We are convinced that patient safety is more important than economics. More …