Head of Department ''BTC, ATMP and IVD Vigilance'' (m/f/d)

We are looking for our SBD 2 “BTC, ATMP and IVD vigilance” as soon as possible

‘BTC, ATMP and IVD vigilance’ We, the Paul-Ehrlich-Institut, are a scientific institution of the federal government which is responsible for the testing and approval of vaccines and biomedical medicines and operates research in the field of life sciences. Networking with national and international actors makes us a competent contact for the public, science, medicine, politics and business.

You are responsible for the technical and disciplinary management of the SBD 2 specialist area, which evaluates the safety of blood products, blood components, tissue and cell preparations (BTC) as well as pharmaceuticals for novel therapies (ATMP). In addition, occurrence reports on in vitro diagnostics (IVD) of class D are evaluated here. The field consists of an interdisciplinary team of employees in the scientific and regulatory field as well as documentation assistants and assistants. (m/w/d) as a specialist area manager, you control and coordinate the operational activities of the area and ensure its quality. These include the planning of inspections of pharmaceutical companies, the initiation and monitoring of measures to improve the safety standards of biomedical medicines, the testing of risk-benefit profiles and the development of optimization proposals for safety standards. As a specialist (m/w/d), you can answer questions from the Institute Management and the Public. You and your employees are represented by the Paul-Ehrlich-Institut in national and international bodies, specialist congresses as well as company discussions and work with working groups or projects. You support the department management conceptually and committed to the further development of the team and the field of expertise and develop strategies for optimising regulatory processes.

Completed academic studies (master or comparable) of life, natural or health sciences (e.g. human medicine, pharmacy, biology, public health) with completed doctoral degree in corresponding subject Competence and first experience in personnel management, team formation and management of an organizational unit Immunological, pharmacological and biomedical knowledge Extensive knowledge and professional experience in the field of drug safety or authorisation German and English knowledge in word and writing Ideally experience with drug studies on the aspect of drug safety Interest in new treatment methods in biomedical medicines Ability to conceptual and strategic action Very good negotiation skills and communication skills Standing for occasional national and international missions Please note that a Declaration of Interests vis-à-vis the EMA as well as a statement in accordance with § 77a AMG must be submitted in the event of the conclusion of the contract.

is a versatile and demanding workplace 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 payment of the year, pension of the company and benefits in terms of assets.

The employment relationship is unlimited. The post shall be transferred as a sample for a period of at least six months. After the probation has been established, the definitive transfer of the function takes place. Parttime employment is generally possible.

The service is in accordance with A 15 BBesO and E 15 TVöD, part I of Appendix 1 of the TVEntgO Bund rated. In principle, a beam is possible and would be carried out in the first transport office of the higher service (A 14 BBesO) in the event of the conditions under which the service is run. In the case of existing civil servants, it is possible to take over up to A 15 BBesO, a corresponding agency is available. The assignment to the stages takes place taking into account the personal relevant experiences.

Disabled applicants (m/w/d) are preferably taken into account with the same suitability. The Paul-Ehrlich-Institut promotes equality between people and the reconciliation of family and work. For this we offer, among other things, very flexible working hours (part-time models, no core working hours), hybrid work (max. 60% remote), kindergarten places and numerous training opportunities. Our company health management and the promotion of the job ticket complete the offer. .