Global Medical Safety Scientist - Munich, Deutschland - ITM Isotope Technologies Munich SE

ITM Isotope Technologies Munich SE

Geprüftes Unternehmen

Munich, Deutschland

vor 3 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

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 crossfunctionally and transnationally
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.