Job opening - Pharmacovigilance Senior Specialist in 東京23区 | Randstad

summary

東京23区, 東京都
¥7,500,000 - ¥11,500,000 per year, 年収750 ～ 1,150万円
permanent

job category
biotechnology & pharmaceutical

job details

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

experience
・Bachelor degree - Required ・Science background - Desirable Minimum Requirements ・Ability to manag

apply with randstad.
Applying with us is easy. We will review your application and see if you are a good fit for the job and the company.
we'll give you a call.
Our consultant will call you at a suitable time to discuss your application and further career aspirations.
getting you registered.
If you’ve never worked with us before, we’ll need some basic additional pieces of information to confirm your eligibility for work.
compliance check.
Next, we just need to verify a few things - we’ll make the relevant compliance checks and keep you posted.
reference and background check.
As part of the process in ensuring you’re perfect for the role, we’ll make contact with any relevant references you’ve provided.
the perfect job for you.
Our expert team will either arrange an interview for the role you’ve applied for, or if they believe there’s a better opportunity, they’ll suggest alternative options too.
the interview.
We’ll ensure that you’re fully prepared ahead of your interview and know exactly what to expect - good luck!
start your new job.
Congratulations, you’re ready to begin your new job. The team will ensure that you’re fully prepared for your first day.

specialist, quality systems & compliance：外資製薬企業
- 東京23区, 東京都
- permanent
- ¥6,000,000 - ¥8,000,000 per year, 年収600 ～ 800万円
社名社名非公開職種安全性管理、品質保証、品質管理業務内容研究開発に投資をしておりパイプラインが豊富。ワークライフバランスの取れる制度が充実している。求められる経験■期待される経験・生物学、微生物学、薬学、化学、化学工学、または関連分野の学位・医薬品業界での品質保証または品質管理経験・GMP、GQP、または関連する規制への理解・ビジネスレベルの日本語と英語力保険健康保険　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600 ～ 800万円賞与-雇用期間期間の定めなし
posted 11 december 2024
社名社名非公開職種安全性管理、品質保証、品質管理業務内容研究開発に投資をしておりパイプラインが豊富。ワークライフバランスの取れる制度が充実している。求められる経験■期待される経験・生物学、微生物学、薬学、化学、化学工学、または関連分野の学位・医薬品業界での品質保証または品質管理経験・GMP、GQP、または関連する規制への理解・ビジネスレベルの日本語と英語力保険健康保険　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600 ～ 800万円賞与-雇用期間期間の定めなし
show job details
ra/qa specialist
- 東京23区, 東京都
- permanent
- ¥6,000,000 - ¥8,000,000 per year, 年収600 ～ 800万円
社名社名非公開職種薬事、メディカルライティング業務内容You'll have the opportunity to work with cutting-edge medical devices while playing a crucial role in bringing them to market through Japan's regulatory landscape, directly impacting patient care and medical advancement.The position offers an attractive work-life balance with flexible work arrangements (including remote work options) and a competitive salary rangeAs a bilingual professional in this role, you'll collaborate with g
posted 22 november 2024
社名社名非公開職種薬事、メディカルライティング業務内容You'll have the opportunity to work with cutting-edge medical devices while playing a crucial role in bringing them to market through Japan's regulatory landscape, directly impacting patient care and medical advancement.The position offers an attractive work-life balance with flexible work arrangements (including remote work options) and a competitive salary rangeAs a bilingual professional in this role, you'll collaborate with g
show job details
senior manager, sales capability：製薬企業
- 東京23区, 東京都
- permanent
- ¥9,000,000 - ¥13,000,000 per year, 年収900 ～ 1,300万円
社名社名非公開職種営業(MR、MS、医療機器)、営業推進業務内容Develop and implement innovative training programs for a dynamic team in the pharmaceutical industry.■About the companyOur client is a leading pharmaceutical company dedicated to improving patient lives through cutting-edge treatments. They foster a collaborative and supportive environment, emphasizing continuous learning and professional growth.■Role & ResponsibilitiesIn this key role, you will design, develop, and deliver
posted 19 november 2024
社名社名非公開職種営業(MR、MS、医療機器)、営業推進業務内容Develop and implement innovative training programs for a dynamic team in the pharmaceutical industry.■About the companyOur client is a leading pharmaceutical company dedicated to improving patient lives through cutting-edge treatments. They foster a collaborative and supportive environment, emphasizing continuous learning and professional growth.■Role & ResponsibilitiesIn this key role, you will design, develop, and deliver
show job details

Thank you for subscribing to your personalised job alerts.

You need to enable JavaScript to run this app.