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新着求人 PMS  (PMS-3)
募集職種 外資系製薬企業の RMP & Epidemiology(Scientist, Department),
Pharmacovigilance Division
勤務地 東京、大阪
会社概要 非公開
求人要件 【職務内容】
Risk Management & Safety Scientists are responsible for setting product safety specifications and for delivery of local Risk Management Plan (RMP), and J-PI (safety parts) to optimize market access from patient safety perspective in Japan.
RMP Team Leads manage setting the project safety strategy in view of ‘Benefit and Risk valance’ of each product by planning the appropriate risk minimization activities and pharmacovigilance plan including regulatory mandatory pharmacovigilance studies collaborated with JPT and Global Strategic Safety Management Team (SSaMT) Leads for JNDA preparation.
Safety surveillance representatives lead to execution of pharmacovigilance activity, and communication of Safety Assurance Measure basically during EPPV period.
• Bachelor’s or higher Degree in Science or related discipline
• 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
【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
• Communication/negotiation skill
• Leadership skill
• Problem solution skill
• Logical thinking
• Business English (Speaking level 6 or above)
• Understanding of PMD Act, relevant regulations, GVP/GPSP and guidelines
• Basic knowledge of pharmacoepidemiology and statistical analysis
• Expertise of medical/pharmaceutical science in general
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