募集要項
- 募集背景
- New role and first hire in PV/PMS department with the establishment of Japan office
- 仕事内容
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Job Description Summary:
The GVP Controller will be responsible for integrating Good Vigilance Practices （GVP） with Chemistry, Manufacturing, and Controls （CMC） to ensure the highest standards of product safety and regulatory compliance. This role requires a highly knowledgeable individual who can bridge the gap between pharmacovigilance and CMC, ensuring comprehensive oversight of product safety while overseeing the collection, assessment, and reporting of adverse events related to our pharmaceutical products. This role requires a detail－oriented individual with a strong understanding of pharmacovigilance regulations and practices.
- 応募資格
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- 必須
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• Bachelor’s degree in pharmacy, Medicine, Life Sciences, or a related field.
• Minimum of 5 years of experience in pharmacovigilance or drug safety within the pharmaceutical industry.
• Strong understanding of Japanese pharmacovigilance and safety regulations and guidelines, including those of the PMDA.
• Excellent analytical skills to assess and interpret safety data and identify potential safety issues.
• Strong written and verbal communication skills for effective safety communication and collaboration.
• High attention to detail to ensure accuracy in safety data management and reporting.
• Strong problem－solving abilities to address safety issues and implement effective risk management strategies.
• Strong organizational skills to manage multiple tasks and projects efficiently.
- 歓迎
- • Advanced degree or certification in pharmacovigilance is preferred.
- 募集年齢(年齢制限理由)
- 定年年齢の上限 （定年年齢を上限として募集するため）
- 雇用形態
- 正社員
- ポジション・役割
- Head of PV & PMS, Anseki
- 勤務地
- 群馬県 / 埼玉県 / 千葉県 / 東京都 / 神奈川県
- 年収・給与
- Competitive
