|募集職種||外資系企業にて Safety Scientist, Science & Data AnalyticsActions の求人（15280）
|求人要件||Safety Scientist is responsible for leading to execution of Pharmacovigilance activities including PMS studies of the products basically post marketing phase including re-examination properly and timely, and for ensuring the Patient’s safety by
To develop and maintain the Risk Management Plan of the products in Japan based on the PV activities’ results and other information.
When the safety issue arises, lead to define the appropriate safety measurement through the communication with the related internal parties including JPV team and Global patient safety with external parties (including co-proportioned company, PMDA and MHLW etc.).
Managing quality Pharmacovigilance deliverables such as RMP(Revision), EPPV report, PMS report, J-PSUR and Re-examination package etc. of the assigned products/projects throughout the product’s lifecycle.
Work on management of PMS study, EPPV and communication of Safety Assurance Measure as PV associate member.
Relevant safety experience or experience elsewhere in Pharmaceutical industry
Cross-functional project team experience
Thorough knowledge of the Pharmacovigilance or drug development process
Written and verbal communication skills
Scientific knowledge sufficient to understand all aspects of safety issues
【資格 / License】
Bachelor's Degree in Science or related discipline
【能力 / Skill-set】
Problem solution skill
Understanding of PMD Act, relevant regulations, GVP/GPSP and guidelines
Basic knowledge of statistical analysis
Expertise of medical/pharmaceutical science in general
【語学 / Language】
English: Business English (Speaking level 5 or above)