Assessors Human Medicine (m/f/d)

We are looking for two positions for our SBD2 “BTC, ATMP and IVD vigilance” as soon as possible as Senior Consultant (m/w/d) Human medicine We, the Paul-Ehrlich-Institut, are a scientific institution of the Federal Institute responsible for the testing and approval of vaccines and biomedical medicinal products and for research in the field of life sciences. Networking with national and international actors makes us a competent partner for the public, science, medicine, politics and business. In the SBD2 area the safety of blood products, blood components, tissue preparations and cell preparations (BTC), will be classified as substances of human origin (substances of human origin – SoHO), as well as pharmaceuticals for novel therapies (ATMP). In addition, case reports on in vitro diagnostics (IVD) of class D are evaluated here, which are used, inter alia, in donor screening.

Evaluation of drug risks and periodic safety reports and the risk of benefits of biomedical medicinal products Processing of suspected cases of undesirable reactions including safety-relevant quality defects in pharmaceuticals and SoHO products Identification and assessment of risks and, where appropriate, initiation of appropriate risk mitigation measures Participation in national and European authorisations and Approval procedure Development of scientific concepts for improving the safety of biomedical medicinal products Advising medical professionals and patients on possible drug effects Approval of training materials and risk communication measures Participation in national and international bodies Please note that a Declaration of Interests vis-à-vis the EMA as well as a statement in accordance with § 77a AMG must be delivered when the contract is concluded.

Completed academic studies (master or comparable) of human medicine with approval Promotion desirable Closed professional training advantageously Joy in the scientific evaluation of complex medical issues Interest in biomedical medicinal products and on drug safety and regulatory requirements Good IT skills (e.g. Microsoft Office, data banks) Analytical thinking and a flexible, independent and structured way of working with a good work organization Team skills and joy in interdisciplinary cooperation Very good knowledge of German and English in word and writing

is a versatile and demanding workstation centrally located in the Rhine-Main area with good connections to the public transport network (car, airport, S-Bahn). As an employer of the public service, we offer the usual social benefits, such as special payments for the year, pensions and benefits. The employment relationship is limited to three years. Parttime employment is generally possible. The two posts are rated according to E 14 TVöD, Part I of Appendix 1 of the TVEntgO Bund. The assignment to the stages takes place taking into account the personal relevant experience. Disabled applicants (m/w/d) are preferably taken into account with the same suitability. The Paul-Ehrlich-Institut promotes the equality of people and the reconciliation of family and work. For this purpose, we offer, inter alia, very flexible working times (part-time models, no core working times), hybrid work (max. 60% remote), kindergartens and numerous training opportunities. Our occupational health management and the promotion of the job ticket complete the offer. .