ABOUT US: Our leading position in the global market in the areas of Aesthetics, Therapeutics, and Consumer Care is the result of our innovative spirit and the commitment of our staff. Our highly attractive portfolio, a strong strategic focus, and dynamic characterize us as a company that is heading towards long-term growth and success. Do you share our enthusiasm for customer oriented work and are willing to take up the task of continuing to write our success story? Then join Merz Aesthetics as Product Safety Associate (m/f/d) Global Product Safety Aesthetics THE FOLLOWING RESPONSIBILITIES ARE AWAITING YOU: You are responsible as Subject Matter Expert to support the application administrator of the relevant databases (e.g. LSS, COGNOS, Tableau, etc.) with respect to data processing and generating reports and queries You optimize, define and implement business processes for processing of Individual Case Safety Reports regarding drug or medical device product in respect of authority requests and laws with focus of quality and efficiency in a timely manner You are responsible for the overview of user accounts of the IT systems used by Product Safety EU/ROW Merz Aesthetics and initiating of corresponding maintenance and modification activities You are responsible for computer system validation (CSV) activities Risk analysis, UAT's) by preparing user requirements and configuration specifications, preparing and executing test scripts and initiating, executing and completing change control procedures according to common guidelines and general terms You initiate change controls with respect to changes in the relevant databases using e.g the JIRA management tool, Preservation and maintenance of products and product groups in Cognos You prepare, revise, review and train SOP's to the respective vigilance databases (e.g. LSS User Manual, LSS training) according to applicable laws/regulations You prepare and support audits and inspections (creation of special reports) in the field of medical device vigilance You are responsible for concept development and management of projects for vigilance activities (e.g. outsourcing projects including commissioning and management of CROs/Service Provider), taking into account priorities and simultaneously ensuring quality and global Goals You are responsible for (Co-) Management of (sub)projects with respect to IT - system upgrades hot fixes and patches and implementation of change requests WHAT WE EXPECT FROM YOU: Scientific university degree combined with information technology knowledge Several years of experience in the field of medical device vigilance Sound knowledge of drug and medical device regulations (e.g. MPG, MDR, AMG, GVP) Knowledge in the processing of ICSRs and in medical coding Systems Sound knowledge and experience with (vigilance) databases A good knowledge of spoken and written English Proficient in MS Office Capable of independent, analytical and conceptual work Careful, reliable way of working WHAT YOU CAN EXPECT FROM US: Meaningful work and exciting projects from day one Collaboration in multi-functional and global teams Flexible work hours Attractive conditions and extensive social benefits Personal & professional development An open & international work environment in a global family-owned business Participation in the company programme "We care for your beauty" YOUR APPLICATION:>> Hier bewerben Then take the next step towards the future with a top employer in the heart of Frankfurt who will offer you freedom to make your own decisions right from the start. We look forward to receiving your online application including your salary expectation, your earliest start date, and the code 1032-120. For more information, visit us at www.merz.de.
Pharma, Chemie, Med.-/ Biotechnologie
Projekt- und Produktmanagement/ Qualitätsmanagement
Chemie/ Pharma/ Biotechnologie
Frankfurt am Main