Safety Assurance Specialist at Abbott

Tokyo, Japan

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Healthcare, PharmaceuticalsIndustries

Requirements

Ability to create technical documents and clear reports
Logical thinking ability
Business-level communication skills in English
Bachelor's degree in pharmacy, chemistry, biology, or engineering, or equivalent practical experience and knowledge
Knowledge of product's scientific, clinical, and basic performance aspects
1+ years of experience in safety management, quality assurance, regulatory affairs, or clinical development (excluding Grade 12), or equivalent experience

Responsibilities

Act as the point of contact for administrative reports related to GVP with authorities and other companies
Properly implement GVP-related regulatory requirements for administrative reports
Collect safety management information and necessary data, evaluate and review it, and develop safety assurance measures
Prepare and submit reports to authorities on adverse events, foreign measures, recalls, etc., within deadlines
Manage progress of safety assurance measures and confirm completion
Create and maintain records related to safety assurance activities
Review attached documents, labeling materials, customer letters, etc., from a GVP perspective
Provide safety data for STED in pharmaceutical applications
Report progress of assigned tasks to supervisor
Collaborate with supervisor and other team members
Perform other tasks instructed by supervisor

Skills

Key technologies and capabilities for this role

GVPPharmacovigilanceRegulatory ReportingSafety ManagementQuality AssuranceTechnical WritingLogical ThinkingEnglish CommunicationSTEDClinical Development

Questions & Answers

Common questions about this position

What is the base pay for this Safety Assurance 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 office-based, and where is it located?

The position is located in Japan > Tokyo : Mita South Tower, with no mention of remote work options.

What are the minimum skills required for this role?

The role requires the ability to create technical documents and clear reports, logical thinking skills, and business communication skills in English.

What education and experience are needed for this position?

Candidates need a bachelor's degree in pharmacy, chemistry, biology, or engineering, or equivalent practical experience and knowledge. Additionally, at least 1 year of experience in safety management, quality assurance, regulatory affairs, or clinical development (excluding Grade 12) is required, along with knowledge of product science, clinical aspects, and basic performance.

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

Strong candidates will have a relevant degree in pharmacy, chemistry, biology, or engineering, plus 1+ years in safety management, quality assurance, regulatory affairs, or clinical development, along with skills in technical writing, logical thinking, and English communication.

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

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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