Safety Process：外資系製薬会社

求人詳細

Safety Process Group is responsible for:
・Deliver training to the members who are responsible for collecting safety information (e.g. sales reps, CRAs, CROs)
・ Support creation of safety information exchange/collection process with relevant parties to facilitate comprehensive and speedy safety data exchange/collection (e.g. global interface organization, safety science, licensees/licensors, clinical study team, medical affairs)
・Support to create and implement case handling process that addresses to the product specific local RMPs if needed
・Ensure safety information (Marketed drug: ICSR; Investigational medicinal product: ICSR, research report, measures taken report, annual report) is submitted without delay to the relevant parties (Regulatory authority, License partners, Clinical Operation, Collaboration partners)
・Accommodate changes of the regulatory requirements and critical business needs
・ Lead planning and execution of training activities with an appropriate network such as functional training coordinators, or other department members
・Lead activities to establish and maintain the framework to ensure an appropriate document recording and archiving
・Self-inspection responsible person: To enhance quality management in both GVP/GPSP control unit and operation unit through self-inspection activities to secure pharmacovigilance activities in compliance with the appropriate standards such as GVP/GPSP
・Contract responsible person: To secure appropriate documentation of safety agreements (mainly GVP/GPSP contract)
・Identify any potential risks/opportunities along with possible contingencies to ensure the appropriate PV activity in order to ensure relevant compliance

こんな方を求めています

経験・スキル

・ Relevant Pharmacovigilance experience in pharmaceutical industry
・Comprehensive understanding of Pharmacovigilance regulatory requirements and business needs
・ Cross-functional project team member experience

学歴

大学卒業以上

募集要項

職種

安全性管理、品質保証、品質管理

給与

年収 800 〜 1,300万円

賞与

-

雇用形態

正社員

雇用期間

期間の定めなし

試用期間

有り
60歳

就業時間

09:00～18:00

休日休暇

土曜日　日曜日　祝日

保険

健康保険,厚生年金保険,雇用保険,労災保険

待遇・福利厚生

単身赴任手当、休日手当など
社宅制度、退職金制度(確定拠出年金)、財形貯蓄制度、融資制度、持株会制度、慶弔見舞金、健康診断、福利厚生倶楽部、ほか

受動喫煙防止措置

敷地内禁煙

特長

女性活躍中, 転勤なし, 外資系企業, 年間休日120日以上, 完全週休2日制, 土日祝休み, 語学力を活かす

業種

医療機器・医療品関連

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