Paul-Ehrlich-Institut

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Peo­ple at PEI

Challenging tasks in the future-oriented life sciences sector, working in an international environment, a good work-life balance – all these aspects distinguish the work at the Paul-Ehrlich-Institut. Our employees can best describe it themselves. They report about their tasks and their career path in an interview.

Linda Füllert, 23, Personnel Unit Employee

Linda Füllert (Source: M.Reiss/Paul-Ehrlich-Institut)

What was your reason for starting a vocational training at the Paul-Ehrlich-Institut?

My attention was drawn to the Paul-Ehrlich-Institut (PEI) during my search for a vocational training course. The institute struck me as being one of the few senior federal authorities in the Rhine-Main Area with a very good reputation in the health sector. What has been and will be attractive for me is the high flexibility in the choice of one’s working hours combined with a high degree of job security – all these are advantages provided by the Paul-Ehrlich-Institut as an employer in the public services, which helps me find an optimum work-life-balance. This is what I appreciate very much.

What was your job start like?

After my A-levels, I first completed a so-called "Voluntary Social Year" working as a sort of intern at a primary school. Then I began my vocational training as office management assistant at the Paul-Ehrlich-Institut in 2016. During my training period, I completed various periods in the different units and section at the Paul-Ehrlich-Institut area of administration. Finally – after I succeeded in com-pleting my vocational training course earlier than required – after only 2 ½ years in 2019 – I decided to work in the personnel unit.

I have only just started my career. For this reason, it is very important for me to make use of further education opportunities steadily and continuously. The Paul-Ehrlich-Institut helped me with my career advancement right from the start of my vocational training. For example, I was able to take part in a seminar on the basics of the collective bargaining contract for the public services in Germany. I have participated in a number of other specialised seminars ever since. That made it simply easier for me to move into professional life and is also very motivating.

What, in particular, do you like about your work at the Paul-Ehrlich-Institut?

In the Personnel Unit, my daily responsibilities include a great variety of important tasks, which I am able to structure and assign to my available working hours without supervision. As a contact for personnel matters, I am also in charge of all concerns related to the employment relationships of colleagues from two divisions of the Paul-Ehrlich-Institut and the smooth course of personnel processes assigned to me. These, in concrete terms include personnel-related measures such as the employment of new members of staff, issuing confirmations for periods of employment, processing changes in the working hours, withdrawals from the Paul-Ehrlich-Institut and many more - all those things related to the topic of employment relationship.

Dr Benjamin Hofner, 38, Head of Section Biostatistics

Statisticians have the best job prospects in many economic sectors – what was your reason for contributing your knowledge to biomedicine?

As statistician, you learn to describe problems of varying nature statistically during your studies, thus contributing to their solution. I discovered my interests in biostatistics as early as my second semester at university, and have specialised in this subject ever since. With regard to life sciences, I made a deliberate effort to become involved in them, since statistical questions are particularly relevant for them. Medical research is particularly dependent on statistical expertise, e.g. for the planning, conduct, and analysis of clinical studies in the development of medicinal products. The aim of these studies is to prove the efficacy and safety of a medicinal product, and they serve us as a prerequisite for a marketing authorisation. My job as a statistician at the Paul-Ehrlich-Institut is the mathematical presentation of procedures in medicines development, to reconsider these procedures constantly, and to provide advice to researching pharmaceutical companies. The research on biomedicines is marked by extremely complex questions. For this reason, exceptional study concepts and complex statistical procedures are used in this area to an ever increasing extent. In some areas, medical progress requires new adaptive study designs, since the latter permit a more rapid transfer from research to clinical use.

What in particular do you like about your job as biostatistician at the Paul-Ehrlich-Institut?

After my previous job as postdoc at the Medical Faculty of University Erlangen-Nuremberg, I was looking for a new challenge, which was even more practically oriented than my previous job, and so I came to the Paul-Ehrlich-Institut in April 2016.

In my function as biostatistician, I co-operate with many divisions of the institute, and in doing so, I have the opportunity to gain a thorough understanding of the development of various medicines – from vaccines via antibodies to blood products. Through providing advice to researching pharmaceutical companies, I experience developments and trends on the biomedicines market at first hand. With regard to advice and marketing authorisations, I am faced with new professional challenges and complex decisions every day. The pros and cons must be weighed carefully, before a decision is made. I enjoy moving in an international closely networked environment in the health system. I contribute my knowledge and experience to the European Medicines Agency EMA, and exchange it with specialists from the field of biostatistics and experts from other medicines authorities.

Since I have just become a father, I also very much appreciate the Paul-Ehrlich-Institut’s commitment to a work-life balance. Thanks to the flexible working hours, I can work from home on some days, and am not tied to fixed periods of presence.

How can your work at PEI be imagined?

The stereotyped idea of a statistician is that of an absolute desk worker. However, the opposite is the case. I take part in many talks, and, in co-operation with the innovation office of the Paul-Ehrlich-Institut, I also join the scientific advice talks. For this reason, it is extremely important to work and communicate in an interdisciplinary fashion. The work at the Institute for me above all also means "training on the job", since we work in a broad range of tasks – both in the marketing authorisation and in research: from the evaluation of the marketing authorisation documents, the support of the methods validation for batch release tests via the planning and evaluation of assays right down to research purposes. Since we are a comparatively small team of biostatisticians, I have to work my way constantly into new statistical methods and new medicines groups for various indications for statistical evaluations. To keep professionally up to date, our team also takes part in national and international research programmes for the advancement and better understanding of statistical methods and study designs. I like the many and varied topics and uses, which help me come into contact with colleagues from different specialised areas. For my work in the Biostatistics Section at the Paul-Ehrlich-Institut, being a team player is a prerequisite.

Martina Koser, 55, Biology Lab Specialist in the Virology Division

What made you start a job at the Paul-Ehrlich-Institut?

After my A-levels, I was looking for a dual education scheme with a focus on natural sciences and good prospects for the future. A vocational training at the Paul-Ehrlich-Institut, for which a new building was constructed at that time, met all of these criteria for me. Thus, from 1984 to 1987, I completed a dual training course as a biology lab specialist, a training scheme offered by the Paul-Ehrlich-Institut in co-operation with Hoechst AG (now Sanofi Pasteur), which I was able to complete in a shorter period of time than regularly required. And after I was given a permanent employment contract, an innovative task was waiting for me, both safe and paid in accordance with a collective bargaining contract. Thanks to my decision for the Paul-Ehrlich-Institut, I also took on a meaningful job that was important for society. Even in the days when the Institute still had its site in Frankfurt, it already enjoyed a very good reputation in our society. For me, it was also important to know that staff members were able to become involved in the staff representative council of the Institute. The possibility of being able to work very flexibly in terms of time was also particularly positive for me. The offer of different working time models convinced me to work with the Paul-Ehrlich-Institut.

What in particular do you like about your work at PEI?

Even after many years at the Paul-Ehrlich-Institut, I still like my field of activity very much. I was able to develop myself constantly, here. I have been given new focuses and challenges, which can also be combined well with my family tasks. I enjoy working independently in the lab and in the team. I really appreciate planning and carrying out experiments on my own responsibility, but also being able to organise my daily routine independently. My colleagues are very understanding, and supervisors are always open to problems and questions. For me, this means high appreciation and it encourages a good working atmosphere. I work part-time in three completely different and demanding work areas. That makes my work extremely appealing.

How can your tasks be imagined?

I work in the Viral Vaccines Section of the Virology Division. Among other things, our tasks include European and national marketing authorisations and viral vaccines such as vaccines against HPV or rotavirus. The practical part of my work involves experimental testing of vaccines for batch release. This means preparation and follow-up of the assays with subsequent analysis and documentation as well as developing and implementing new test procedures.

Another focus of my work is preparing batch notifications and certificates for the pharmaceutical manufacturers and the documentation. Besides, I’m in charge of organising and monitoring the testing media. This means that I check the temperature and the functionality of the equipment and am responsible for the maintenance of the databases. In our sphere of responsibility, we strictly adhere to predetermined quality guidelines. We are thus required to work with great care and accurately. In my sphere of responsbility, I can draw on several years of experience. Therefore, I also take charge of trainings and organising the appropriate training plans. Besides, I'm involved in the annual reviews of my section.

Supervising trainees and interns is another task I perform. I’m very happy to be able to share my knowledge and work with our junior colleagues. Through medical progress and developments in research, my working areas constantly change, and there are always new exciting tasks and challenges.

Dr Susanne Müller, 60, Deputy Head of Unit Pharmacovigilance 2 and Clinical Assessor

Susanne Müller (Source: B.Morgenroth/Paul-Ehrlich-Institut)

What did your professional life look like before you joined the Paul-Ehrlich-Institut?

Before working at the Paul-Ehrlich-Institut, I was able to gain extensive medical and later on regulatory experience. For a long time, I worked as a specialist medical doctor for anaesthetics, intensive care, analgesics and the emergency medicine in various maximum care hospitals and university hospitals. After that, at first, I worked at the Clinical Research Organisation (CRO), where I had a management position in the field of medicines safety working on behalf of various pharmaceutical companies. As project manager, I was also responsible for the economic success of my projects.

What made you decide to change to Paul-Ehrlich-Institut?

I was curious. As medical doctor, I had gained experience in a hospital, then gained insights into the pharmaceutical industry, and finally wanted to know how a senior authority reached their important evaluations and decisions. During my work as a clinical assessor at the Paul-Ehrlich-Institut, I can optimally combine my medical and regulatory experience. Here, I can actively contribute to making medicinal products even safer, both at European and national level. In this context, my practical experience as specialised doctor really provides me with the necessary basis and goes a long way towards helping me with my regulatory work. I can only recommend working in a clinical setting first to gain clinical experience before changing over to regulatory affairs, since the practical experience in the clinical treatment of patients is an important prerequisite for effective and at the same time reasonable regulatory measures. Lateral entrants who want to switch from medicine to regulation are therefore very welcome at the PEI and their professional input is highly valued.

Altogether, the Paul-Ehrlich-Institut is a very interesting and versatile employer for scientists in the field of the life sciences. Above all, the usually genetically manufactured so-called advanced therapy medicinal products (ATMPs) are both an exciting field of research for all those interested in biology, biotechnology, and medicines development, and a challenge for regulation. This is because developments in this area give rise to hope for new therapeutics against serious diseases such as cancers or rare genetic disorders for which no sufficient treatments are yet available. These medicinal products are granted a centralised marketing authorisation in all EU member states, so that regulatory activities in this context are planned for the whole of Europe. Since the responsibility for the marketing authorisation and monitoring of ATMPs in Germany is with PEI, my colleagues are very close to new developments in medicine.

Last but not least, I very much enjoy facing constantly new challenges, no matter whether this is in the field of work organisation, e.g. with regard to the use of new databases and other information technologies or in evaluating new modes of action of medicines and research approaches, or in organising new workflows. Such workflows are of course completely different in a clinical context as compared with a federal institute working in regulation. In my professional life up to now, I have been able to experience very differing working environments, each of which were intriguing and challenging in their own way. I don't want to miss any of them.

How can your current work at the Paul-Ehrlich-Institut be imagined?

By changing from a clinical environment to pharmaceutical safety and regulation, I have exchanged surgery, the intensive ward, and the direct work with patients against a desk job. This is definitely also versatile and challenging.

I have to tackle a great variety of tasks on a typical working day. They range from the evaluation of the reports on suspected cases of adverse effects, which require a broad medical knowledge, the assessment of the safety profiles of medicinal products, the assessment of study protocols for the testing of the medicinal products in post-marketing interventional studies to identify possible risk signals and/or long-term effects, right down to ordering measures for the safety of blood donations. It is not unusual that medical professionals or patients call us when they have questions concerning the safe use of medicines. To be able to judge the relevant safety aspects of a medicinal product, I often have to study the disease patterns and the modes of actions of the medicines very thoroughly. For this reason, most of my time is taken up by preparing the authorisation-relevant safety aspects of new ATMPs and new medicines in general during the marketing authorisation process as well as post-marketing. During these processes, I closely co-operate with colleagues of other European medicines authorities, the European Medicines Agency EMA, and the different sections of the Paul-Ehrlich-Institut.

Updated: 13.08.2021