Clinical Safety Specialist (m/w/d)

Clinical Safety Specialist (m/w/d) Job ID: 57828 Location: Wien, AT Job Level: Professionals Job Category: Research and Development Employment Type: Permanent position Career Level: Octapharma specializes in the development of highly pure pharmaceuticals made of human blood plasma. As part of a family-owned enterprise, Octapharma in Vienna is not only the largest production site, but also a successful research location of the Octapharma Group. Since our company continues to grow, we are now hiring for our team: Your new challenges which will inspire you: Supporting the Clinical Safety Project Lead in managing and executing safety-related activities within clinical trials Coordination and standardization of safety management tasks and reporting activities at different sites, including preparation of study-specific safety management plans Support with the development and implementation of new safety processes related to the upcoming Safety Database, including the transitions to new electronic reporting formats and improvements in SAE reconciliation processes Perform SAE case triage, data entry, query, and reporting obligations under the supervision of the Clinical Safety Project Lead Collaborate with cross-functional teams to ensure efficient safety data management, including streamlining PV narrative writing and enhancing electronic data capture (EDC) systems for safety reporting Track the status of safety reference information (CIBs), DSUR distribution, and approvals Support the preparation of regulatory documents, such as PSURs, DSURs, and CIBs, under the guidance of the Clinical Safety Project Lead Contribute to developing regular clinical summaries for the EU QPPV, focusing on signal detection in clinical trials Your profile that will convince us: University Degree in natural sciences or clinical sciences Experience in clinical safety or related field within clinical research Knowledge of safety regulations and reporting requirements Strong organizational and analytical skills, with attention to detail Ability to work effectively in a team and communicate with various stakeholders Fluent English is a must, German is beneficial for local team communication, but is not mandatory Our attractive benefits for you: Wide range of tasks in an international setting, flexibility and personal responsibility Reliable employer with generous employee benefits and a salary customary in the market. Familiar setting of a family-owned enterprise with benefits such as Do & Co staff restaurant, extraordinary staff events and many more: Additional information: The minimum gross wage according to the collective agreement (chemical industry) for your new job is EUR 4.157,14. We strive to adapt your salary to your range of tasks and to your profile, which is why we are ready to pay wages higher than collectively agreed. We are looking forward to new, committed employees who join forces with us to promote our strong growth in order to keep enabling our patients to live a better life - because it is in our blood! Is it in your blood too? We are looking forward to receiving your application via our online career portal. Your contact: Jakob Lueger, B.A.Octapharma Pharmazeutika Produktionsges.m.b.H.Oberlaaer Straße 235, 1100 Wien,T: +43 0664 88338501 About OctapharmaHeadquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. Octapharma employs nearly 12,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Immunotherapy, Haematology and Critical Care. Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 195 plasma donation centres across Europe and the US. Octapharma has 40 years of experience in patient care.