Specialist, Drug Safety

Specialist, Drug Safety

Responsibility & Role

We are working on clinical study derived safety information (mainly in oncology area) including case management, summarizing clinical safety information of investigational drugs according to GCP for clinical study site, and review/development of clinical study related documents such as protocol. In addition, to ensure moving forward many clinical studies appropriately, we are also working together with stakeholders such as clinical departments, regulatory affairs, quality management and CRA etc. In case of case management, even a single delay or violation of GCP can result in a loss of confidence in PMDA, clinical study sites and the public. For this reason, we work every day to assure that the case management is without compliance issues and that we cooperate with stakeholders involved in clinical study to contribute to the development of new drugs.

• Responsible for all aspects of safety information management (collection, assessment, reporting) related to investigational drugs such as ICSR, literature, aggregate report and safety measures taken in foreign countries etc.
• Responsible for working closely with clinical related department for preparation and reviewing of documents, especially safety related part for clinical study
• Ensure issuing clinical safety information of investigational drug according to GCP for reporting to clinical study site
• Ensure response and readiness for the GCP Document-based conformity inspection
• Ensure negotiate with our partner companies regarding exchange of clinical safety information for clinical study

Required Qualification

• At least 2 year experience of case processing or working experience in clinical development (an additional experience of case processing for Oncology products is preferable)
• Knowledge about safety related laws and regulations
• Basic knowledge about pharmaceutical and/or medical science (Bachelor's degree or above on pharmaceutical or medical science field is preferable)
• English ability sufficient enough to translation(Japanese ⇔ English) of AE case reports, understanding of English literature and e-mail communication
• Business communication skill with stakeholders within/outside of the company
• Business operation management skill, especially punctual for timelines
• Open mind for change and proactive behavior
• Self-motivated to build collaborative and productive relationship with others