住所Position
This is the position of Safety Management Specialist at the Commercial Quality Abbott Diagnostics Medical Co., Ltd.
This position is so called “Anseki” to deploy and implement post marketing surveillance according to the GVP (Good Vigilance Practice) regulations, which is required by the Japanese Pharmaceutical Law.
Job Description
This position is required the following roles and responsibilities.
Deploy and monitor post marketing surveillance requirements in accordance with the Japanese pharmaceutical regulations and Abbott Quality Standards in the local commercial organization.
Audit and Inspection readiness support and remediation of the audit related corrective actions from GVP perspectives.
Monitor and judge for escalated complaints whether or not to be reportable to the Japan authority and Abbott global as PRE (Potentially Reportable Event) .
Quality Incident/CAPA/Document control and implementation.
Implementation of Management Review from GVP view-points on quarterly basis.
Implementation of GVP trainings for Abbott Diagnostics Medical Co., Ltd. organization, distributors and 3dr party Logistics as well.
Experience
More than a three -year experience of GVP activities related to pharmaceutical, IVD, Medical Device industries.
Knowledge and Skill
GVP/QMS ordinance or related regulations, e.g. ISO 13485
Communication, discussion and negotiation skills with local authorities PMDA, MHLW, and Abbott global organizations.
English skills to read and write vigilance documents
Location
Shinjuku office (7F SHINJUKU NS Bldg. 2-4-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo)
