Head of PV & PMS,Ansekiの転職・求人情報 27981587

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: 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

必須: • 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.

事業内容・会社の特長: An U.S. bio venture company that has shown substantial growth in global with various product pipelines including their groundbreaking gene therapy drug approved in the U.S. that is the first and only treatment that addresses the genetic cause of a type of rare disease.