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.
Our effort includes hands and hearts.
Which is why we don´t just offer nice advice, but take an active part in accomplishing your projects. We take responsibility for their appropriate and timely execution. Whether this is in
- Periodic Safety Update Report creation,
- Correct Suspected Unexpected Serious Adverse Reaction (SUSAR) reporting,
- Input for a Risk Management Plan,
- Conducting an Audit
- Preparation for a Pharmacovigilance inspection or
- Strategic consultancy
- we find solutions in close cooperation with you.
If you don´t have the necessary resources for your own Pharmacovigilance function, we may be of help in sharing this responsibility. If so desired, this may include the functions of the Qualified Person responsible for Pharmacovigilance / back-up procedure or the Graduated Plan Officer (‘Stufenplanbeauftragter’, Germany).
Patient safety first is in our opinion a derivative of the very term ‘Pharmacovigilance’: It is the essential core of this function to use vigilance and care when looking after the safety of drugs planned to be or already marketed. On behalf of patients as well as the companies producing and distributing those drugs. This task is close to our hearts.