【浜離宮勤務】Safety Surveillance Specialist（植込み型補助人工心臓） at Abbott

Tokyo, Japan

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Ability to handle post-marketing safety management tasks for implantable assist artificial hearts
Processing capacity equivalent to or above Specialist level; Sr. Specialist requires leadership and guidance of team members

Responsibilities

Customer Focused Quality [C]
Collection, review, evaluation, and timely administrative reporting (15/30 days) of foreign cases and foreign measures safety information
Creation of customer letters and handling inquiries related to customer letters
Review of new package inserts, creation of package insert revision proposals, and management of revision schedules
Review of handling instructions and marketing tools
Pre-product launch risk assessment
Planning of safety assurance measures, instructions to related departments (e.g., recalls (modifications, patient monitoring), information provision), creation of necessary documents, and progress management of information provision/patient monitoring
Collaboration with other departments (at product launch, FCA, projects, etc.)
Management of external vendors related to safety management (e.g., Fuji Xerox (package inserts), JAPIC (measure information), IMIC (literature information, translation))
Analysis of post-marketing defect trends in Japan and collaboration with related departments (including manufacturers), planning and implementation of measures for quality maintenance
Audits of Vigilance Reporting team's operations (part of GVP self-audit)
Active participation in process improvements, new process launches, and projects
Vigilance Reporting [V]
Collection, review, evaluation, and timely administrative reporting (15/30 days) of domestic, literature, and infectious disease safety information
Acquisition of additional information and responses to inquiries from overseas manufacturers (Comm Hub)
Compliance with adverse event reporting and product return deadlines (2-day rule/15-day rule)
Consultation with PMDA on PMS case PMDA reporting criteria during PMS planning
Involvement in creating PMS collaboration procedures and collaboration with PMS group based on procedures
Review of PMS cases and spontaneous report evaluations, creation of GVP-related documents for PMS re-examination applications
Audits of Customer Focused Quality team's operations (part of GVP self-audit)
Process Monitoring [P]
Construction and maintenance of monitoring processes for Customer Focused Quality and Vigilance Reporting teams' performance and processing capacity
Monitoring of safety information intake (Daily), start/completion status (Weekly), PMDA reports (deadlines, volume), Comm Hub responses (deadlines, volume, time)
Monitoring of individual administrative report completion volume and individual work-in-progress duration
Monitoring of individual customer report completion volume and individual work-in-progress duration
Planning, instruction, execution, and progress management of process improvements and processing capacity improvements
Record keeping and storage for specific medical devices (receipt, registration, storage, and recovery rate of tracking sheets, etc.)
General (Sr. Specialist)
Leadership and guidance of team members in addition to the above responsibilities
Processing capacity equivalent to or above Specialist level

Skills

PMDA Reporting

GVP

Post-Market Surveillance

Vigilance Reporting

Risk Assessment

Regulatory Compliance

Document Review

Process Monitoring

Safety Management

Pharmacovigilance

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees