The future belongs to those who drive innovation, inspire transformation and fuel collaboration. Our commitment is achieved by working together with our clients in combining the key technologies IT, Engineering and Life Sciences in order to develop innovative solutions for the future. We connect top companies with the sharpest minds in Life Science. All of them united by their burning passion to make use of their talents in order to master the challenges ahead. Are you one of them?
If so, you are what we are looking for as a co-worker for a project by one of our customers, a renowned company in the sector of biotechnology located in Planegg, close to Munich. Commencing immediately on a or permanent basis.
What you can do for us
- Your key tasks are to provide technical safety expertise to ensure the scientific integrity and quality of all relevant clinical development and post-marketing activities and deliverables, including signal and risk management, benefit-risk assessments, clinical trial protocols and reports, submission documents (BLA/MAA), and publications
- You are a core member of the product-specific Safety Management Team(s)
- You provide state-of-the-art safety scientific methodology for safety data analysis, visualization and interpretation, collaborating closely with biostatistical colleagues
- Keep up-to-date with technical development of tools for use in analysis, interpretation and presentation of safety data, and use this knowledge in the development and implementation of such tools at MorphoSys
- You maintain an appropriate level of knowledge about relevant products and therapy areas
- Keep up-to-date with developments in clinical safety and pharmacovigilance regulations and practice
- Your task is also to present safety-related data, information and messages to internal and external audiences as required
- Demonstrate knowledge of, and ensure compliance with company guidelines, policies and procedures and be able to demonstrate this during health authority inspections
The skills that are needed
- You completed successfully university or equivalent studies in a life science discipline i.e. in biology, chemistry, pharmacy; a higher qualification (e.g. Masters degree) is preferred
- Several years of relevant industrial experience
- You provide pharmaceutical industry experience in clinical research and/or clinical drug safety (both post-marketing pharmacovigilance and clinical development)
- Sound knowledge and understanding of industry and pharmacovigilance legislation, including ICH-GCP and clinical safety guidelines, EU Clinical Trials Directive and EMA GVP Modules, and FDA clinical safety and risk management guidance, and the need for compliance
- Close cross-functional collaboration, including with Biostatistics, Regulatory Affairs, Clinical Development, Medical Affairs, C&QA, Non-clinical drug safety, CMC
- Excellent communication skills, oral and written – ability to present information clearly and concisely
- Strong team-working skills – working across cultural and functional boundaries
- Able to prioritise, adapt rapidly to changes in priorities, and manage multiple situations/issues, remaining calm and delivering under pressure
- Strategic thinking, problem-solving and decision-making ability
- Excellent written and oral communication skills in English, including grammatical/technical writing and presentation skills
Why you are in the right place when working with us
We connect the right professionals with the right project, as we do by connecting you with our recruiting projects! Our path together begins with trying to comprehend your ambitions. We shall work together to help you achieve your career objective, by investing in your professional development and mentoring, and by coaching you throughout your career. Modis is a global leader in professional solutions and a dynamic brand with a global focus. We are pursuing ambitious goals in a key market. Our affiliation with Adecco Group opens up a wide array of career choices for you.
You can hardly wait to get to know us? Then a simple click will quickly connect you with us. Just click on "APPLY NOW“ to send us your application.
Herr Tilman MarkowetzBewerbung.FreiburgLS@modis.com
Phone +49 761 38908 213www.modis.com