医薬品安全管理責任者

Job Details

【求人タイトル】

16928 医薬品安全管理責任者

【職務内容】

1. Responsibilities as National Safety Officer under SOPs and Safety Manager(安全管理責任者) under GVP ordinance
・Establish and maintain a local PV System
・Ensure cooperation in the Global PV System Update Routine, ePUR
・Establish and maintain a Personal File
・Continuous education by attending regularly PV trainings
・Establish and maintain an Out of Office Hours Availability
・Ensure the conclusion of PV Agreements whenever PV Service Providers execute PV activities on behalf of the MU
・Ensure the establishment and maintenance of local SOPs whenever necessary
・Collect ADRs from all sources including local literature search
・Ensure screening of medical enquiries for ADRs
・Ensure establishment and maintenance of local registers (e.g. Excel sheet) for Pregnancy cases, Other Post-marketing Activities, CAPA, and Websites / Chat rooms
・Enter all collected cases of ADRs in COSI in a complete, accurate and timely manner
・Retract all cases which are reportable to local authorities from COSI
・Submit all reportable cases according to local law
・Enter the submission date of all reported cases in COSI
・Perform regular ADR reconciliation in Other Post-marketing Activities, company websites / chat rooms, medical enquiries, PV Service Providers / distributors
・Handle appropriately late cases
・Consider cases from special reporting
・Ensure PV training
・Prepare and maintain annual local PV Training Plan
・Issue and hand out PV training certificates
・Archive copies of PV training certificates and / or list of participants
・Prepare and maintain annual local PV Audit Plan
・Monitor all safety variations
・Monitor all Risk Minimization Measures as part of a Risk management Plan
・Communicate regularly with contracted PV Service Providers / distributors / etc. and keep records of all contacts
・Oversee and control regularly company websites / chat rooms
・Record all PV activities and archive all related source data and documents appropriately
・Planning preventative action and negotiating with Japanese authority about planned prevent action
・Correspondence to queries from the health authority about safety issue
・Preparation of audit by TMG/Global audit team and correspondence to queries
2. Preparation/Maintenance of Package Insert
・Preparation of package insert for NDA
・Revision of package insert of existence product when necessary
3. Oversight of activities/deliverables of PV service providers
・Review of safety assessment of ICSR evaluated by PV service provider
・Review of CIOMS prepared by PV service provider
・Work closely with a staff of service provider to make sure appropriate case processing with no delay reporting/no-incompliance
4. Oversight of safety activities of distributers as Safety manager (安全管理責任者)
5. Collaboration with team member
・Support to director of RA/QA/Safety division to accomplish business target
・Support to division members to accomplish business target

【応募要件】

Behavioral Competencies:
・Cross-cultural communication skill
・Team Building skill
Functional Competencies:
・Grasp overview of business project
・Business & market awareness
・Negotiation Skills
Fluently in English:
・Understanding of scientific literature
・Writing in e-mail
・Speaking in teleconference
Experience & Academics:
Knowledge
・GVP ordinance
・GPSP ordinance
・ICH, Japanese regulatory requirements
・Handling of safety data on clinical trials
Preferable
・More than 5 years’ experience in Pharmacovigilance division
・Experience of safety manager(安全管理責任者)
・Experience of re-examination submission and PMS
Organizational Knowledge
・Understand the company systems and processes- QA, QC, Marketing, Sales, Customer service, IT, HR, GA, Finance, Manufacturing, Supply chain, Warehouse
・Understand the global culture and different business manner
Personal Style:
・Be based on scientific evidence
・Take careful consideration
・Accepts reality
・Self-starter

【会社概要】

グローバルに展開するヘルスケア企業です。 重篤な慢性疾患領域の医薬品及び医療機器の開発、製造、販売などを行っています。

【注目ポイント】

安責の経験が無い方でも安全性部門での経験が5以上あればチャレンジいただけます!グローバルとのコミュニケーションも担当するため、ご自身の英語力も磨いていただけます。ご興味がございましたら、是非お早目にお問い合わせください!

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