[JDSU] 医薬品安全性統括部 ケースマネジメントチーム（一般社員） （Staff, Case Management, Japan Drug Safety Unit）
Pfizer · JP
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About the Role
This role is responsible for collecting and assessing safety information for marketed and investigational Pfizer products, entering and managing data in the Global Safety Database, and ensuring compliance with Japanese, US, and European regulations. The position also involves contributing to audits, regulatory inspections, and projects related to global safety processes.
Responsibilities
- Collect and assess safety information (adverse events) of marketed and investigational Pfizer products.
- Enter and manage data in the Global Safety Database.
- Ensure compliance with Japanese, US, and European laws and regulations.
- Support domestic and foreign internal audits and regulatory inspections.
- Respond to regulatory queries regarding Individual Case Safety Reports.
- Participate in projects related to the development of global safety processes.
Requirements
- Fluent Japanese language capability (able to understand and explain Japanese regulations in Japanese, and develop regulatory documents in Japanese).
- Medical qualification (e.g., Registered Pharmacist) or a science background from college or above.
- Ability to practically and constructively identify and solve daily challenges.
- Ability to make decisions with a clear expectation of outcomes.
- Ability to achieve personal goals while meeting departmental work standards.
- Ability to work effectively in a team.
- English verbal communication and writing skills (TOEIC score of 600 or higher required, 730 or higher preferred).
Skills
- PC skills
- Pharmacovigilance experience (preferred)
- Safety data management experience (preferred)
- Medical writing experience/skill (preferred)
- Experience relating to Safety Database (preferred)
Location
- Tokyo Headquarter
Work Type
- Hybrid
About the Company
- Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
- To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.
Equal Opportunity
- Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.