Dr. Monika Boos
Who I am
I am Dr. Monika Boos LL.M. - the heart of the
BoosConsulting.
I am a licensed human medicine doctor (doctor), have a doctorate in clinical pharmacology, am trained as a pharmaceutical technical assistant (PTA) and obtained a Master's degree in pharmaceutical law (Master of Laws).
I am a licensed human medicine doctor (doctor), have a doctorate in clinical pharmacology, am trained as a pharmaceutical technical assistant (PTA) and obtained a Master's degree in pharmaceutical law (Master of Laws).
I am also TUEV-certified AI Compliance Officer.
In addition to my multidisciplinary training, which enables me to adopt different perspectives, I bring experience from pharmacies, hospitals, doctor's offices, the pharmaceutical industry and self-employment to my assignments - in particular my 20+ years of pharmacovigilance practice.
Clients thus benefit from an integrated overall approach to their challenges.
Clients thus benefit from an integrated overall approach to their challenges.
What characterises me
A high-quality education, comprehensive specialist knowledge, many years of professional experience as well as analytical thinking, structured work, accuracy, and reliability are among my strengths. This is also reflected in the client testimonials.
During my 10
years
of
experience
in
research-based,
internationally
operating
pharmaceutical
companies, in which I learned drug safety from the ground up, I was able to gain work experience at national/German, but also at European and global level.
I am therefore familiar with both, working in an Affiliate (national/German branch) as well as the challenges at European or global level (Global PV, Headquarters PV).
I am therefore familiar with both, working in an Affiliate (national/German branch) as well as the challenges at European or global level (Global PV, Headquarters PV).
From a simple Drug Safety Officer, to team and group leadership (also in matrix structures across countries, continents and organisations), to (deputy) Graduated Plan Officer / EU QPPV, to Head of Corporate Pharmacovigilance, I have acquired practical skills in almost all pharmacovigilance activities. This includes clinical
safety
as well as pharmacovigilance in the post-authorisation
/ post-marketing
area.
» I am familiar with the situation of my clients from my own years of experience, so I can clearly understand what is important and provide targeted support with relevant expertise. «
In addition, I now bring 10+
years
of
experience
as
a
self-employed
person
in which I have, for example, helped Big Pharma with manpower, written documents such as RMPs or PSURs or PSMFs for medium-sized companies, identified new relevant risks in the signal management process, advised family-run pharmaceutical companies and non-commercial sponsors, acted as EU QPPV and/or UK QPPV in international companies, taken on team/department management, prepared companies for Inspections / Audits, guided them through Inspections in relevant functions and/or set up/implemented CAPAs with them, performed Audits, set up PV systems for start-ups / SMEs or modified the PV system for established companies and carried out many other activities. In addition, I have held numerous training courses, seminars and presentations and lectures, written specialist articles, columns and book contributions and am involved in national and international associations in my field.
Active memberships
Partner:
Member:
International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) →
Lead of the Pharmacovigilance Group
Previous memberships
International Society of Pharmacovigilance (ISoP)
Former Board Member of the German Society of Pharmaceutical Medicine (DGPharMed e.V.), General Editor “PM QM” (Specialist Journal for Pharmaceutical Medicine and Quality Management), Head of Press and Public Relations as well as (2016-2021) Chair of the division "Pharmacovigilance"
