Patient Safety Physician

vor 1 Monat

Wien, Österreich Octapharma Vollzeit

Job ID: 58204- 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**:

- **Study Safety Data Management**:

- Develop and maintain the Safety Management Plan
- Track SAEs, and facilitate SAE triage and narrative preparation, perform SAE causality and expectedness evaluations; SUSAR management, MedWatch preparation
- Keep safety reference information up to date, provide input in DSUR, PSUR, IBs
- Review study safety AE listings, answer medical questions from the sites and study team
- Participate in safety signal detection activities, including reviewing post-marketing listings
- **Study Medical Monitoring**:

- Develop a medical monitoring plan to oversee clinical CRO activities
- Lead internal medical review meetings, ensuring the quality and safety of emerging blinded aggregated study data
- Ensure the accuracy of safety language in ICFs and Protocols
- Attend IDMC meetings; participate in study risk management meetings
- Keep the Clinical Strategy Medical Lead informed of emerging medical issues and risks
- Provide safety reporting and protocol training to new employees, study teams, and investigators

**Your profile that will convince us**:

- Medical degree with specialization in a relevant field
- Experience in clinical safety and pharmacovigilance
- Strong understanding of clinical trial processes and regulatory requirements
- Excellent communication and teamwork skills
- Fluent in English, German is advantageous Ability to manage multiple tasks and prioritize effectively**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 salary 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 salaries higher than collectively agreed.

**Your contact**:
Jakob Lueger, B.A.
Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Straße 235, 1100 Wien,
T: +43 0664 88338501

**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.

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