Global Medical Safety Scientist

vor 1 Monat


Munich, Deutschland ITM Isotope Technologies Munich SE Vollzeit

**Your Role**:

- CSR preliminary assessment and medical review in Argus Safety
- Contribute to medical safety relevant sections in Aggregate safety reports (PSURs, DSURs, etc)
- Contribute to medical safety relevant sections of Risk Management Plans
- Elaborate and maintain list of safety concerns
- Perform signal detection and safety signal assessment
- Act as safety matter expert in the development and maintenance of product information (IB, CCDS, local/ region labels)
- Evaluate, review, and approve assessments of safety findings from literature
- Prepare responses to safety inquiries received from internal or external stakeholders
- Collaborate for the preparation of safety materials for internal and external safety and labelling boards
- Manage and assess SAE reconciliation discrepancies and provide medical safety input for their resolution

**What we are looking for**:

- Medical Doctor; previous clinical experience is a plus
- Solid organizational skills to enable working in a large corporate matrix environment; Experience working cross-functionally and trans-nationally
- At least 3, ideally 5 years of previous experience in a similar role in the pharmaceutical industry or CRO; Oncology experience preferred
- Experience to work in safety databases, ideally Argus Safety
- High proficiency with Microsoft Office including PowerPoint presentations, Excel Spreadsheets
- Solid project and time management skills
- Demonstrated leadership skills, with a proactive, strategic mindset
- Fluent written and spoken English

**What we offer**:

- A modern workplace and exciting opportunities in an evolving and fast growing company
- Challenging and varied projects in interdisciplinary, multicultural and highly professional teams
- A collegial corporate culture and short communication channels
- Flexible working hours with an attractive salary package and diverse corporate benefits

At ITM, we work together towards one common goal - the benefit of our patients. This is what drives us, every day. This is what we are passionate about. For this we create opportunities that are as unique as our team. We encourage diversity and inclusion - the input of our multi-cultural employees makes us who we are.

Only together we can contribute to significantly improving the outcome and quality of life of cancer patients worldwide and to giving better answers than “maybe”.

Does this sound like you? Are you interested in shaping the future of ITM and joining one of our highly committed teams in an innovative work environment?

Then send us your detailed CV including earliest start date and salary expectations. The position is intended for the ITM Oncologics GmbH, a company of the ITM group. Applications are accepted either in German or English language.



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