PV Manager

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募集要項

会社概要

同社は様々な製品を提供する世界有数の医薬品、健康管理事業を行っている米国企業の日本法人です。
診断薬・機器、医薬品、病院用製品、栄養剤など多彩な製品群を持ち、診断から治療まで広範囲にカバーする高品質・高機能の製品とサービスを提供し、高い評価を得ています。もちろん部門間での異動や情報共有もされており、総合ヘルスケアメーカーとして圧倒的な地位を築いています。

業務内容

Manage the collection, processing and assessment of safety related information as it relates to the company's Nutrition products in compliance with applicable regulatory requirements and guidelines, as well as division and corporate level policies and procedures; Ensure the pharmacovigilance (PV) system for the company's Nutrition products registered as drugs in Japan is in place and is compliant with regulatory standards; Maintain the PV IT system used for adverse event reporting. The manager is considered a subject matter expert in the area of pharmacovigilance.
Main responsibilities:

• Manage the Japan PV team (through guidance and supervision) in the collection, review, and assessment of adverse event reports/safety related information
• Ensure submission of reportable adverse events to the health authority in accordance with requirements and timeframes outlined in local regulations
• Develop and maintain local standard operating procedures that are aligned with corporate/division level policies and procedures and follow local regulations
• Develop and provide PV training for new/junior team members and local affiliate staff
• Serve as the point of contact for all local PV activities, inquiries and issues, including responding to inquiries from the health authority
• Prepare and submit periodic reports to the health authority in compliance with local regulations
• Conduct internal inspections of the PV system as required by local regulations
• Serve as the PV lead during internal audits and external inspections; prepare and execute CAPAs for any PV related findings
• Participate in the review of promotional materials
• Act as the safety database administrator, including coordinating maintenance and upgrades of the PV IT system
• Manage vendor and process associated with searching of scientific literature for safety related information
• Participate/collaborate with the Medical Safety & Surveillance team on global safety/pharmacovigilance related initiatives and goals
• Functions independently as a decision-maker within specified parameters and decisions could potentially have financial ramifications or impact brand reputation, regulatory compliance, or patient and product safety. 
• Individual is recognized as an internal subject matter expert and resource with responsibilities that require high level critical thinking and analytic abilities.
• Leads cross-functional projects related to the area of expertise with a high level of visibility across the local affiliate site. 
• Responsible for ensuring compliance with local regulatory requirements related to pharmacovigilance for Japan’s drug products.   

応募条件

Minimum requirements:

• Master's degree in related health science area (pharmacy or nutrition desirable) or equivalent skills, education or experience
• 7+ years of experience working in pharmacovigilance for drug or nutritional products
• Sound knowledge of local (Japan) nutritional/pharmacovigilance regulations  
• Experience managing direct reports and leading complex projects related to pharmacovigilance/product safety
• Fluency in spoken/written Japanese and English
• Computer proficient (Windows, Word, Excel); experience working in adverse event/safety databases
• Excellent communication and interpersonal skills, both written and spoken
• Strong organizational skills with proven ability to prioritize and work on multiple tasks and projects
• Strong commitment to compliance with the relevant rules and procedures and to scientific quality and integrity

給与

1000 - 1300 万円

勤務地

東京