About the Role
Pfizer is seeking new talent to join their global community to unearth innovative therapies that make the world a healthier place. This role is crucial in maintaining safety compliance for marketed and investigational products.
Responsibilities
- Collect and assess safety information (adverse event information) of marketed/investigation Pfizer products.
- Enter and manage data on the Global Safety Database.
- Ensure compliance with Japanese, US, and European laws and regulations, and maintain safety compliance.
- Contribute to 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 operational processes.
Requirements
- Fluent Japanese language capability (able to understand and explain Japanese regulations in Japanese, and create regulatory documents for submission 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 the department's required work standards.
- Ability to work as part of a team.
- English verbal communication and writing skills.
- TOEIC score of 600 or higher (required), or 730 or higher (preferred).
Skills
- PC skills
- Pharmacovigilance and/or Safety Data Management experience (preferred)
- Medical writing experience/skill (preferred)
- Experience relating to Safety Databases (preferred)
Location
- Tokyo Headquarter
Work Type
- Hybrid
Education Level
- College or above (Science background)
- Registered Pharmacist or equivalent medical qualification
About the Company
- Pfizer's culture emphasizes individual ownership and the belief in their ability to improve future healthcare and transform millions of lives.
- Pfizer is a medical company focused on discovering innovative therapies.
Equal Opportunity
- Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
- Candidates should review candidate AI-use guidelines available on Pfizer Careers for acceptable and prohibited uses of AI during the recruitment process.
