[Osako or Tokyo] Drug Safety Associate

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Job details

Company overview

Our client is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.

Responsibilities

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.

Requirements

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.

Salary

8 - 14 million yen

Location

Osaka