Sr. Specialist, Safety Vigilance/安全管理シニアスペシャリスト at Alcon

Tokyo, Japan

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Medical DevicesIndustries

Requirements

Science university degree (medical, biology, etc., preferred)
Ability to communicate in English with global teams (e.g., email)
Interest in safety management tasks
Basic knowledge of regulations such as the Pharmaceutical and Medical Device Act (GxP experience preferred)
Report writing ability (experience with administrative reports preferred)
Ability to work collaboratively in a team
Logical thinking skills
Enjoyment of learning new knowledge outside one's expertise
Smooth communication with other departments (e.g., internal phone calls)

Responsibilities

GVP-related tasks under the Pharmaceutical and Medical Device Act
Handling safety management information in line with global requirements
Collection and evaluation of safety management information (from healthcare professionals, general consumers, literature, administrative sources, surveys, etc.) for pharmaceuticals, medical devices (Class I-III), and quasi-drugs (involves communication with other departments)
Planning and implementation of measures for safety management information (e.g., reporting malfunctions to regulatory authorities)
Maintenance of records related to safety management information
Education and training
Internal audit and external audit対応
Communication with overseas Alcon staff and vendors (in English)

Skills

GVP

薬機法

安全管理

リスク評価

規制報告

英語コミュニケーション

レポート作成

GxP

内部監査

外部監査

Alcon

Specializes in eye care products and solutions

About Alcon

Alcon specializes in eye care products and vision solutions aimed at improving people's quality of life through better vision. Their product offerings include solutions for cataract surgery, retinal health, and contact lenses. Alcon's products work by utilizing advanced technology and research to provide effective treatments and aids for various eye conditions. What sets Alcon apart from its competitors is its strong emphasis on research and development, ensuring that they remain leaders in the eye care industry. The company's goal is to enhance vision and overall quality of life for individuals while promoting a diverse and inclusive workplace.

Geneva, SwitzerlandHeadquarters

1945Year Founded

IPOCompany Stage

Social Impact, HealthcareIndustries

10,001+Employees

Benefits

Medical, dental, & vision coverage

HSA Medical Plan

PTO

Paid Parental leave

401k

Retirement Plan Company Contribution

Low payroll deductions

Tuition Reimbursement Program

Annual Bonus

Free Family Contact Lens Program

12 Company Paid Holidays

Risks

FDA recall of contact lenses may harm Alcon's reputation and financial standing.

Antitrust case denial could lead to legal challenges and financial penalties.

Innovative competitors like Signal12 threaten Alcon's market share in eye care.

Differentiation

Alcon leads in eye care with a broad product portfolio and global reach.

The company invests heavily in R&D, ensuring cutting-edge vision solutions.

Alcon's commitment to diversity and inclusion strengthens its corporate culture.

Upsides

Acquisition of BELKIN Vision enhances Alcon's glaucoma treatment options with DSLT technology.

Orbis Flying Eye Hospital project boosts Alcon's global presence and eye care standards.

Recognition as a top employer in Singapore attracts and retains top talent.

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