gvp specialist/senior specialist i global medical device company.

Lead impactful global vigilance and pharmacovigilance initiatives in a dynamic and collaborative environment.■About the companyOur client is a leading global medical device company with a strong presence in Japan. They are committed to patient safety and are seeking a highly motivated individual to join their growing team. The company fosters a collaborative and supportive work environment.■Role & ResponsibilitiesYou will play a critical role in ensuring the safety and compliance of medical devices in the Japanese market. You will be responsible for handling customer complaints, adverse event reporting, and collaborating with internal and external stakeholders to maintain regulatory compliance. You will be at the forefront of ensuring patient safety and contributing to a culture of vigilance.■Main tasks include・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.If you are interested in this exciting opportunity, apply now.We look forward to hearing from you.

求められる経験
■Requirements
・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.
・Experience with global complaint handling systems.
・Basic level English communication skills.
・Demonstrated commitment to patient safety.

保険
健康保険　厚生年金保険　雇用保険

休日休暇
土曜日　日曜日　祝日

給与
年収650 ～ 750万円

賞与
+10％
雇用期間
期間の定めなし