Intern - Drug Safety Location : Germany - Berlin (Mitte) Fix Term (6 months-contract, 40 hours per week) Einstellendes Unternehmen : Shire Deutschland GmbH, ein Vertriebsunternehmen der Takeda Gruppe Under the direction of Head of Drug Safety Europe & South EMEA, the Student Intern (m / f) receives a comprehensive introduction to the company, the department and the most relevant Global Drug Safety policies and processes.
The Student Intern is responsible for fulfilling the training program customized for this purpose and to make her / him familiar with the pharmacovigilance requirements stated in the companies Drug Safety SOPs and WIs and in the pharmacovigilance legislation, to support the department’s operative activities and to provide administrative support.
Collection of safety information, follow up for additional information and reporting to health authorities Support collection, documentation, and processing of adverse events.
Ensure consistent and effective follow up according to global procedures Monitor status, quality and submission due dates for adverse event reports originating from DACH countries on regular basis Support the regular update and maintenance of case tracking tool Local Regulation Activities Familiarize with relevant legislation, participate in regular case conferences and contribute to inspection / audit preparation activities as required Training Activities Ensure timely fulfillment of all SABA assigned trainings to meet the expected 100% compliance Undertake timely and relevant training for the role including relevant GDS policies and procedures Attend relevant internal PV trainings to ensure an adequate and up-
to date state of knowledge Other Activities Contribute to the department’s administrative tasks on a regular basis Track email group account of department Support the monitoring of metrics and compliance Participate in regular local, regional and global team meetings Education & Experience Requirements Currently immatriculated in a University in Germany Minimum : undergoing Bachelor Study Program Preferred : Bachelor Degree educated, currently undergoing Master Study Program Key Skills, Abilities & Competencies Strong attention to detail in composing and proofing-
reading materials, establishing priorities, scheduling and meeting deadlines Ability to work independently, take initiative and complete tasks to deadlines Excellent oral and written communication skills, interpersonal skills and cultural awareness Fluent in German and English (both spoken and written) Very good knowledge in Microsoft Office applications and databases Internal & External Contacts Regular interaction with Drug Safety Leads on a local, regional and global level Interfaces with external stakeholders (clinical research organizations, home care services, etc.
This sounds interesting to you? We are looking forward to hearing from you. For questions related to the position or the recruitment process, please contact Ms.
Maxi Gruber (maxi.gruber takeda.com) Notice to Employment / Recruitment Agents : Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-
owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal.
Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-
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