Translational Research, Safety Leader
Contribute to Safety Studies at the Translational Phase
Work with an Industry Leading Global Pharmaceutical Company
- Global leader in the pharmaceutical industry with rich development pipeline in onco-immuno therapies, cardiovascular, ophthalmology/CNS, rare/orphan diseases
- Plan safety risk management in early phase research and development projects.
- Monitor safety in early phase clinical studies
- Manage queries from regulatory authorities in and outside Japan.
- Involved in the establishment of a PV system for multi-regional clinical trials, etc.
- Work closely with project teams and overseas counterparts.
- Knowledge of the principal regulations and guidelines related to handling safety information during clinical development.
Logical, scientific thinking ability and document composition ability.
Ability to negotiate in a global business environment.
Knowledge related to nonclinical studies/clinical studies/clinical pharmacology is a plus.
- Solid experience with activities related to safety measures (clinical development or postmarketing).
- Experience with clinical science activities in clinical development (irrespective of disease area).
- Experience related to nonclinical studies/clinical pharmacology is a plus.
- Opportunity to lead global safety studies at the translational research stage
- Work closely with overseas counterparts to manage studies safely and effectively