社名
社名非公開
職種
安全性管理、品質保証、品質管理
業務内容
...
Job Summary:・Lead adverse event (AE) reporting job including maintenance of pharmacovigilance (PV) information technology (IT) system. Ensure compliance with local regulations and the company Policy/standard operating procedures (SOPs).ROLE & RESPONSIBILITIES1. Ensure compliance with local regulations and the company Policy/SOPsa. Collect, review and analyze safety information timely and properlyb. Keep the due date for expedited reports without any late reportingc. Review and confirm reportability and causality of the adverse drug reaction (ADR) cased. Prepare safety report for E2B reporting formate. Handle inspection/audit and reply to inquiries by the authorities/HQs for case levelf. Maintain and upgrades of the PV IT system timely and properly2. Prepare or review Periodic Report for unexpected / Non-serious Adverse Drug Reactions and Reports of measures taken overseas, and Research reports such as literature reports.3. Support to prepare new package insert (PI) and revise current PI (Revision of Precautions) in timely manner for appropriate use of ANI product in Japan.4. Review promotion materials as PV Senior specialist5. Support to maintain local SOPs consistency with the company global policy/ SOPs6. Plan and perform education/training for new staff/junior staff in related field7. Control record retention8. Provide regular education and trainings for MRs and other relevant personnel9. Support handling inspection/audit and reply to inquiries by authorities/corporate in related field10. Conduct Affiliate Safety Representative (ASR) or ASR backup activities in compliance with the company Nutrition Medical Safety and Surveillance policy.
求められる経験
・Bachelor degree - Required
・Science background - Desirable
Minimum Requirements
・Ability to manage multi task effectively -Required
・PC skill: - Required
・English skill: Reading and Writing - Required
・Excellent communication and interpersonal skills, both written and spoken -Required
Preferred Requirement
・Experience: Working in Pharmacovigilance for drug - 3+year experience (5+years CRO experience) - Desirable
・Knowledge of Database and system development - Highly desirable
・English skill: TOEIC score 600 - Desirable, Speaking – Highly desirable
保険
健康保険 厚生年金保険 雇用保険
休日休暇
土曜日 日曜日 祝日
給与
年収750 ~ 1,150万円
賞与
-
雇用期間
期間の定めなし
show more
社名
社名非公開
職種
安全性管理、品質保証、品質管理
業務内容
Job Summary:・Lead adverse event (AE) reporting job including maintenance of pharmacovigilance (PV) information technology (IT) system. Ensure compliance with local regulations and the company Policy/standard operating procedures (SOPs).ROLE & RESPONSIBILITIES1. Ensure compliance with local regulations and the company Policy/SOPsa. Collect, review and analyze safety information timely and properlyb. Keep the due date for expedited reports without any late reportingc. Review and confirm reportability and causality of the adverse drug reaction (ADR) cased. Prepare safety report for E2B reporting formate. Handle inspection/audit and reply to inquiries by the authorities/HQs for case levelf. Maintain and upgrades of the PV IT system timely and properly2. Prepare or review Periodic Report for unexpected / Non-serious Adverse Drug Reactions and Reports of measures taken overseas, and Research reports such as literature reports.3. Support to prepare new package insert (PI) and revise current PI (Revision of Precautions) in timely manner for appropriate use of ANI product in Japan.4. Review promotion materials as PV Senior specialist5. Support to maintain local SOPs consistency with the company global policy/ SOPs6. Plan and perform education/training for new staff/junior staff in related field7. Control record retention8. Provide regular education and trainings for MRs and other relevant personnel9. Support handling inspection/audit and reply to inquiries by authorities/corporate in related field10. Conduct Affiliate Safety Representative (ASR) or ASR backup activities in compliance with the company Nutrition Medical Safety and Surveillance policy.
...
求められる経験
・Bachelor degree - Required
・Science background - Desirable
Minimum Requirements
・Ability to manage multi task effectively -Required
・PC skill: - Required
・English skill: Reading and Writing - Required
・Excellent communication and interpersonal skills, both written and spoken -Required
Preferred Requirement
・Experience: Working in Pharmacovigilance for drug - 3+year experience (5+years CRO experience) - Desirable
・Knowledge of Database and system development - Highly desirable
・English skill: TOEIC score 600 - Desirable, Speaking – Highly desirable
保険
健康保険 厚生年金保険 雇用保険
休日休暇
土曜日 日曜日 祝日
給与
年収750 ~ 1,150万円
賞与
-
雇用期間
期間の定めなし
show more