Lead impactful global vigilance and pharmacovigilance initiatives in a dynamic and collaborative environment. The role involves managing customer complaints, adverse event reporting, regulatory compliance, and contributing to patient safety in the Japanese market.
業務内容:
Manage and register complaints on local and global complaint handling systems
Collect and document medical device safety information from various sources
Propose safety measures based on the Japan Decision Tree
Create and submit timely adverse event reports to PMDA
Prepare and send customer letters based on investigation reports
Report on safety measures to relevant stakeholders
応募資格:
Bachelor's degree in life sciences or a related field
3+ years of experience in GVP or pharmacovigilance within the medical device industry
Excellent communication and presentation skills in Japanese
Proficient in MS Office Suite (Excel, Word, PowerPoint)
Experience with regulatory reporting to PMDA
Strong problem-solving and analytical skills
Ability to work independently and as part of a team
