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新着求人 PMS  (PMS-3)
募集職種 外資系製薬企業の Safety Science & PMS Scientist
勤務地 東京、大阪
会社概要 非公開
求人要件 【職務内容】
Post Marketing PV & Safety Scientist is responsible for leading to execution of Pharmacovigilance activities of the products basically post marketing phase including re-examination properly and timely, and for ensuring the Patient’s safety by:
・ Maintaining 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 Global patient safety with relevant in-house members and external parties (including co-proportioned company, PMDA and MHLW etc) .
・ Managing quality Pharmacovigilance deliverables such as RMP(Revision), PMS (interim and final)report ,J-PSUR and Re-examination package of the assigned products/projects throughout the product’s lifecycle
・ Work on management of CEI/sCEI operation, PMS data management, management of EPPV, or 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
【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
・ Bachelor’s Degree in Science or related discipline
・ 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 statistic analysis
・ Expertise of medical/pharmaceutical science in general
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