Senior Medical Operations Manager For Pms

BeOne Medicines Ltd

Japan, Japan
On-site
Develop and revise sops for pms
Plan pms aligned with risk management plan
Negotiate with pmda regarding pms
BeOne Medicines Ltd is seeking a Senior Medical Operations Manager for Post Marketing Surveillance (PMS) in Japan. The role involves overseeing compliance with Japanese regulations, coordinating with various medical affairs functions, and contributing to the company's mission of improving cancer treatment access

Job Summary

  • The Senior Manager, Medical Operations for Post Marketing Surveillance (PMS) is responsible for all aspects of PMS, including planning, conducting, and managing activities in compliance with Japanese regulations and GVP/GPSP guidelines.
  • This role will assist leadership in growing and building with other medical affairs functions and involves engagement across all functions of medical affairs.
  • BeOne offers a market competitive compensation package, company shares, and in-house and external learning and development opportunities.

Matching Summary

Match Score: 85

BeOne Medicines Ltd is seeking a Senior Medical Operations Manager for Post Marketing Surveillance (PMS) in Japan. The role involves overseeing compliance with Japanese regulations, coordinating with various medical affairs functions, and contributing to the company's mission of improving cancer treatment access.

Skills & Requirements

Must-have

  • Develop and revise SOPs for PMS
  • Plan PMS aligned with Risk Management Plan
  • Negotiate with PMDA regarding PMS
  • Select appropriate vendors for data collection
  • Develop and implement self-inspection program
  • Ensure GPSP compliance in PMS activities

Nice-to-have

  • Highly motivated and collaborative
  • Passionate interest in fighting cancer
  • Positive attitude and flexibility

Key Requirements

  • Over 8 years of experience in the pharmaceutical industry
  • More than 5 years of experience in PMS and epidemiologic research
  • Experience as head of PMS preferred
  • TOEIC score of 720 or higher

Work Rights

Not specified

Tailored Resume

Cover Letter