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Manager or Staff, Product Safety

Publication date 2020/06/9

Tokyo,7.0M ~ 13.0M

Global Major Pharmaceutical Company

Description of Primary Role & Responsibility
- Develop local aggregate reports (J-PSUR, J-DSUR, NUPR, J-Infection report, etc.) and re-examination application report
- Develop regulatory query responses and regulatory safety commitment reports other than above
- Monitor domestic/foreign safety information of marketed/investigational products and propose safety measures
- Contribute to development of investigational products as JMT/JVT members
- Lead development/revision of J-RMPs, and manage them properly
- Prepare and respond for inspection (GVP/GPSP/GCP inspection, Company internal audit)
- Participate in projects related to building of business processes including global organization

Desired Behavioral and Technical Skills
- Basic regulatory/medical knowledge related to pharmacovigilance
- English skills including writing/speaking/listening (TOEIC score : ≧730)
- High sense and enthusiasm for pharmacovigilance
- Cooperativeness (team work) and leadership (ownership)
- PC skills (Word/Excel/Power Point)

Desired Experiences
- Medical qualifications such as pharmacists, or science background
- Pharmacovigilance or equivalent experience preferred
- Experience handling safety data preferred
- Participation in global project preferred

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