[Osako or Tokyo] Drug Safety Associate

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募集要項

会社概要

臨床試験における総合的な業務をフルサービスで提供する開発業務受託機関です。

業務内容

THE DRUG SAFETY ASSOCIATE WILL WORK ON SAFETY EVALUATION WORK FOR PHARMACEUTICAL PRODUCTS (INCLUDING INVESTIGATIONAL PRODUCTS), MAINLY INDIVIDUAL CASE EVALUATION, CASE PROCESS WORK AND RELATED WORK

• UNDERSTAND THE OPERATION OF THE SAFETY DATABASE AND THE SYSTEM NECESSARY FOR THE WORK, AND CREATE MANUALS, ETC. AS NECESSARY. 
• RESPONSIBLE FOR-FAMILIARITY WITH SAFETY INDIVIDUAL CASE EVALUATION WORK IN COMPLIANCE WITH GVP AND SOP, AND INSTRUCTING OTHER MEMBERS
• PROPOSING MEASURES AND IMPROVEMENT POINTS FOR PROBLEMS THAT MAY AFFECT BUSINESS PROCESSES, ETC.
• COMPLIANCE DOCUMENT BY REGULATORY AUTHORITIES COOPERATE IN PREPARATION AND RESPONSE TO SURVEYS, ETC.

応募条件

EDUCATION:

• UNIVERSITY GRADUATE OR ABOVE (PREFERABLY PHARMACEUTICAL / BIOLOGICAL) OR MEDICAL (NURSE, CLINICAL LABORATORY TECHNICIAN, ETC.)
• ENGLISH: CONVERSATION
• JAPANESE: NATIVE

WORK EXPERIENCE:

• EXPERIENCE IN INDIVIDUAL SAFETY CASE EVALUATION WORK IN THE PHARMACEUTICAL INDUSTRY (2 YEARS OR MORE) 
• EXPERIENCE INUSING SAFETY DATABASE (ESPECIALLY ARGUS / J)
• ENGLISH THAT CAN READ INDIVIDUAL CASE REPORTS (ENGLISH) DESCRIBED IN CIOMS FORM WITHOUT HESITATION ABILITY
• PEOPLE WHO CAN HANDLE BASIC ENGLISH SUCH AS E-MAIL AND DOCUMENT CREATION BY THEMSELVES
• PEOPLE WHO HAVE EASY-TO-UNDERSTAND AND ACCURATE COMMUNICATION SKILLS FOR THE OTHER PARTY
• COLLABORATION IN COOPERATION WITH INTERNAL AND EXTERNAL STAKEHOLDERS THOSE WHO CAN WORK-THOSE
• WHO HAVE A HIGH AWARENESS OF LEGAL COMPLIANCE
• THOSE WHO CAN WORK WITH AN EMPHASIS ON ACCURACY WHILE PAYING ATTENTION TO DETAILS WHILE BEING COST-CONSCIOUS.

給与

800 - 1400 万円

勤務地

その他