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.
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
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.