【R&D】Safety Scientist, Science & Data Analytics (Staff / Individual contributor)
【職務内容 / Job Description】
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.
【経験 / Experience】
- For Internal Candidates; Must be from BioPharma
- 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
＜歓迎 Nice to have＞
- Pharmacovigilance activities , Drug development or regulatory affairs experience in outside of Japan
- Working with external bodies, such as co-marketing companies and advisory board members, as a leading person
【資格 / License】
- Bachelor's Degree in Science or related discipline
【能力 / Skill-set】
- Communication/negotiation skill
- Leadership skill
- Problem solution skill
- Logical thinking
- Understanding of PMD Act, relevant regulations, GVP/GPSP and guidelines
- Basic knowledge of statistical analysis
- Expertise of medical/pharmaceutical science in general
【語学 / Languages】
- Business English (Speaking level 5 or above)
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