Safety Operation Staff, Safety Operation Group, Pharmacovigilance /ファーマコビジランス 【製薬オンライン】製薬会社・製薬メーカー・製薬企業・医薬品・医療機器等の製薬・医療業界の求人転職サイト

受付時間 平日9時~20時まで 土曜9時~17時まで 03-6278-8721

製薬業界専門の転職・求人サイト 製薬Online.com
最終更新日: 2018年 09月 19日

求人情報

ファーマコビジランス

求人管理No.012654

会社概要

Safety Operation Staff, Safety Operation Group, Pharmacovigilance

アウトソーシングされたベンダーと協力して、規制当局の要件、社内手続き書類および安全協定に従って、関係者に安全情報を収集し、評価

募集要項

・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)
・Create and implement case handling process that addresses to the product specific local RMPs.
・Ensure safety information is reported without delay from relevant parties.
・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).
・Support obtaining follow-up information from relevant parties.
・Input requirements to safety systems (e.g., TODAY, CW, LogTri)
・Maintain knowledge of the disease areas for marketed products and investigational products to effectively interface business and science needs to case handling
・Ensure compliance targets are continuously met
・Accommodate changes of the regulatory requirements and critical business needs
・Ensure KPI targets of outsourced vendor are continuously met (quality / performance)
・Escalate any actual/potential compliance issue to an appropriate person (e.g. the line manager) and contribute to resolve

Additional Responsibilities (for band Over D)
・Lead the other group staff to standardize and visualize process
・Effectively work as a liaison in a outsourced vendor- client partnership
・Identify any potential risks/opportunities along with possible contingencies to ensure the appropriate PV activity in order to ensure relevant compliance
・Proactively participate in skill-development, coaching, and performance feedback of the other group staff
・Support or lead case handling related issue management

募集条件

  • ・Bachelor’s Degree in Science or related discipline
    ・Relevant Patient Safety experience in pharmaceutical industry
    ・Cross-functional project team member experience
    ・ad and coach the other staff to ensure prioritized objectives that focus on the critical activities and identify any potential risks/opportunities along with possible contingencies to ensure the appropriate PV activity in order to ensure the patient’s safety.
    ・Proven leadership and project management experience
    Business English (Speaking level 6 or above)
    ・Understanding of PMD Act, relevant regulations, GCP/GVP/GPSP and guidelines
    ・Basic knowledge of statistic analysis
    ・Expertise of medical/pharmaceutical science in general

    Preferred Experience
    ・Pharmacovigilance activities, drug development or regulatory affairs experience outside Japan
    ・Working with external bodies such as outsourced vendors and co-development companies as a leading person

勤務開始日

  • 応相談

雇用形態

  • 正社員

勤務地

  • 大阪、東京

転勤有無

  • 当面なし

勤務時間

  • フレックスタイム制度あり

給与

  • ご経験に応じての額となります。