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Clinical Safety Project Lead

vor 4 Monaten

Wien, Österreich Octapharma Vollzeit

Job ID: 57829- 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**:

- Ensure the efficacy and safety of interventional clinical trials by coordinating safety management tasks across multiple company sites and studies
- Act as a matrix lead for multiple Safety Medical Experts, who align and coordinate their activities and the activities of other stakeholders involved in safety management tasks
- Standardize safety reporting activities, review clinical study protocols to ensure compliance with safety reporting regulations, develop new EDC and Safety Database integration processes, and improve overall safety procedures
- Provide input at CRO clinical bid defense meetings, selection and contracting
- Oversee and coordinate the preparation of study safety reporting plans, including the coordination of activities carried out by Safety Medical Experts
- Develop and implement CR&D processes in anticipation of the new Safety Database and coordinate CR&D activities regarding input for PSURs, DSURs, and CIBs, ensuring a global overview of timelines and status
- Coordinate the triage of SAE from interventional clinical trials, including data entry, SAE query process, and assessment by safety physicians
- Perform and oversee expedited safety reporting to EMA, coordinate submission of IND safety reports to FDA
- Oversee SAE reconciliation, PV narrative writing processes as well as post-marketing safety listings review process
- Reporting directly to the Head of CR&D in Vienna

**Your profile that will convince us**:

- University Degree in natural sciences or clinical sciences
- Several years of professional experience in clinical safety management
- Experience within the pharmaceutical industry, preferably with safety management experience (PV, clinical safety)
- Familiarity with global clinical safety regulations and reporting requirements
- Strong project management skills with the ability to effectively manage multiple tasks and stakeholders
- Excellent communication and interpersonal skills, capable of working closely with cross-functional teams
- Fluent English is a must, German is beneficial for local team communication, but is not mandatory
- Willingness to travel internationally

**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 3.909,67. 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.

**Your contact**:
Marina Ibrahim, M.A.
Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Straße 235, 1100 Wien,
T: +43 (1) 610 32 - 1308

**About Octapharma**:
Headquartered 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.