[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) at Pfizer | Tokyo, Japan | Rezi

[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) at Pfizer

[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 · Tokyo, Japan

1 months ago

[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 · Tokyo, Japan

a month ago
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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.