Pharmacovigilance Manager

Location Tokyo
Job type Permanent
Salary 8,000,000 - 12,000,000 JPY
Reference 32921

【COMPANY OVERVIEW】

A privately funded global Biopharmaceutical Company with locations in the USA (Corporate Headquarters and R&D ) and regional offices in Asia and Europe. The company`s mission is to offer new, safe, and effective cancer treatment options that could transform and improve the lives of patients.

【JOB RESPONSIBILITIES】

  • Research and analysis on the events/adverse events including device deficiencies, and reports to regulatory authorities (individual cases, various periodic reports) in a timely manner.

  • Lead to define the appropriate safety measurement through the communication with the related Global and external parties whenever safety issues arise.

  • Ensure full compliance with applicable pharmacovigilance regulations in Japan.

  • Oversee all activities or responsibilities that are delegated to external parties.

【WHY YOU SHOULD APPLY】

  • Be a part of a growing global company and be a part of their success story.

  • Excellent company culture

  • Work with a global team environment

【REQUIREMENTS】

  • Knowledge of relevant safety / pharmacovigilance in Pharmaceutical industry (Experience in drafting periodic reports is preferred.)

  • Experience in both clinical and post-marketing environment.

  • Understanding of PMD Act, relevant regulations, GVP/GPSP and guidelines.

  • Good communication and problem solution skill among cross-functional team.

  • Ability to communicate reading, writing, and speaking in English.

  • Experience in using safety database and data entry experience required (Argus is preferred)

  • Experience in handling safety information of medical device is preferred.