Company Overview
A company in the healthcare industry is hiring for a Post-Marketing Safety Management Specialist position. This organization operates globally and is dedicated to advancing patient care through innovative medical technologies, particularly in minimally invasive treatments. With a strong commitment to improving patient outcomes, the company fosters a collaborative and inclusive work environment where professionals can contribute meaningful ideas and grow their careers while supporting life-changing therapies.
Job Description
Collaborate with the local Quality Officer and global teams to ensure post-marketing safety compliance in Japan in alignment with regulatory requirements such as GVP and GPSP.
Lead post-marketing safety management activities including the collection, analysis, and review of safety information from spontaneous reports, literature, and country-specific sources.
Implement safety assurance measures, including regulatory reporting, voluntary recalls, and dissemination of safety information.
Develop and execute risk management plans, including post-marketing studies and surveillance activities.
Manage labeling activities such as creation, maintenance, and revision of product labels and instructions, coordinating with regulatory authorities when needed.
Plan and deliver training programs, conduct self-inspections, and ensure proper documentation and record management.
Coordinate with overseas manufacturing sites to integrate Japan-specific safety data into the global vigilance system.
Qualifications
Associate’s degree or higher in a scientific field, with a bachelor’s or master’s degree preferred
At least five years of experience in the medical device industry
Qualification to serve as a Safety Management Officer under the Japan Pharmaceuticals and Medical Devices Act
Strong project management and administrative skills
High attention to detail with excellent organizational and record-keeping abilities
Strong verbal, written, and analytical communication skills with the ability to collaborate effectively across teams
Ability to work within established quality systems and ensure compliance with internal policies and regulatory standards
Benefits
Health insurance
Employees’ pension insurance
Employment insurance
Industrial injury insurance