Medical Safety Associate

Vor 6 Tagen


Nuernberg, Deutschland Novocure Vollzeit

Location: Munchen, DE, 81925- Description:

- Novocure is a global publicly-traded commercial-stage oncology company developing a profoundly different cancer treatment therapy called tumor treating fields (TTFields) for patients with solid tumors. TTFields therapy is a non-invasive, novel, antimitotic treatment modality which utilizes proprietary technology attempting to slow or reverse tumor progression by inducing tumor cell death. Novocure's commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma (GBM) in the USA, Europe and Israel. Novocure has ongoing or completed clinical trials and is further expanding its efforts into several other solid tumor indications - non-small cell lung cancer, pancreatic cancer, ovarian cancer and other types of solid cancers.

To support our team in Munich, Germany we are looking for a

**Medical Safety Associate**

The **Medical Safety Associate **is a position assisting in managing the mandatory safety reporting requirements for the commercial program and other functions of the Medical Safety Group (MSG) within the Global Commercialization Team.

**Your responsibilities**:

- Investigate medical complaints received within the commercial program
- Manage medical data input into the safety database
- Perform review of Medical Records for complaint information
- Support Literature review activities
- Execute the processing and defined work flow steps of medical complaint information received by the MSG and the preparation of internal and external reports
- Evaluate medical complaint information from worldwide sources and ensure follow-up information is requested within predetermined timelines
- Communicate with healthcare professionals to collect, evaluate, and document information on reported medical complaints as needed using medical knowledge, experience and communication skills
- Write medical case narratives
- Support the review of medical complaints received by MSG for completeness and consistency
- Participate in the compilation of aggregate reports per USA and international regulations
- Compliance with corporate and department SOPs and conventions while maintaining a working knowledge of global medical device safety guidelines and requirements
- Participate in special projects as assigned

**Your profile**:

- Minimum qualifications: Bachelor’s level degree preferably in Life Sciences, nursing, pharmacy or other health related profession;
- 1 year experience in pharmaceutical/medical device company and/or minimum 1-2 years in a healthcare setting
- Ability to understand and evaluate technical, scientific and medical information
- Demonstrate competence in obtaining, analyzing, disseminating and reporting safety information in compliance with applicable regulations
- Ability to analyze case and query data and communicate results and propose recommendations
- Ability to effectively communicate with healthcare professionals
- Highly organized and demonstrates understanding of workflow prioritization
- Ability to multitask and triage as needed
- Work with others in contributing to the overall success of the company
- Fluency in German and English, Written and Spoken.



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