【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

Key technologies and capabilities for this role

PMDA ReportingGVPPost-Market SurveillanceVigilance ReportingRisk AssessmentRegulatory ComplianceDocument ReviewProcess MonitoringSafety ManagementPharmacovigilance

Questions & Answers

Common questions about this position

What is the salary for this Safety Surveillance Specialist position?

The base pay for this position is N/A. In specific locations, the pay range may vary from the range posted.

Is this role remote or onsite, and where is it located?

The position is located at Hamarikyu Park Side Place 9F, 17F, 5-6-10, Tsukiji, Chuo-ku, Tokyo, Japan, indicating an onsite role at this specific office.

What key skills or experiences are required for this role?

The role requires expertise in post-market safety management, including collection, evaluation, and timely regulatory reporting (15/30 days) of safety information, risk assessment, document review, process monitoring, and collaboration with departments and vendors. Sr. Specialist level additionally involves guiding team members with equivalent or superior processing capabilities.

What does the team structure look like for this position?

The role is part of teams handling Customer Focused Quality [C], Vigilance Reporting [V], and Process Monitoring [P], with Sr. Specialist positions involving a guiding role for team members.

What makes a strong candidate for this Safety Surveillance Specialist role?

Strong candidates have experience in pharmacovigilance for implantable medical devices, proficiency in regulatory reporting deadlines, process improvement projects, and for Sr. Specialist, leadership in guiding team members with high processing efficiency.

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