募集要項
- 募集背景
- 新規雇用
- 仕事内容
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Job Duties:
－ Authors new and updates to SOPs and Working Instructions and conduct related training.
－ Contribute to standardize on PV/PMS process and workflow, and support to implement and maintenance the safety database.
－ Create the annual GVP/GPSP training and education plan, manage the training record and create the annual report.
－ Creates the annual GVP/GPSP self-inspection plan and the report to PV director. Performs the self inspection if needed.
－ Maintains and stores the GVP/GPSP essential document based on the Japan regulation and global SOPs.
－ Collaborates with the stakeholder at the external/internal audit and the Regulatory Authority Inspection.
－ Takes initiative in the ongoing process improvement for quality and compliance.
－ Monitors that PV service vendor performance is appropriate, and they are following the contract and project management plan.
- 応募資格
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- 必須
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－Well informed on relevant PMDA/MHLW and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post marketing environments required.
－Demonstrated success in working with cross functional teams (RA, Sales, Marketing and clinical development)
－Contributes to and manages organizational projects and goals to support their timely completion.
－Experience with supporting or leading regulatory authority inspection such as PMDA Reexamination, MAH license renews and GCP Reliability Inspection.
－Experience with managing complex projects, such as function/team improvement project, Safety Database implementation project, Business license succession including safety data transferring.
－GVP/GPSP self-inspection
－Drug Safety experience in pharma space
- 募集年齢(年齢制限理由)
- 長期勤続によりキャリア形成を図る為 （長期勤続によりキャリア形成を図るため）
- 雇用形態
- 正社員
- 勤務地
- 埼玉県 / 千葉県 / 東京都 / 神奈川県
- 年収・給与
- 1300万円 ～ 1500万円ベース給与 + ボーナス + LTIs
