Assoc Safety Spec- (Fluent in reading and writing in Japanese)

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Essential Functions

• Performs day-to-day PV activities. May participate in on-call duties for specific
• projects to ensure 24-hr coverage for intake of cases from investigative sites.
• Reviews regulatory/pharmacovigilance publications and information sources to
• keep updated on current regulations, practices, procedures and proposals.
• Maintains medical understanding of applicable therapeutic area and disease
• states.
• Reviews cases entered for quality, consistency and accuracy, including review of peer reports.
• Prepares and maintains regulatory safety reports.

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• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).

• Strong critical thinking and problem solving skills
• Good oral and written communication skills including paraphrasing skills
• Good command of English and ability to translate information into local language where required
• Computer literate with the ability to work within multiple databases
• Previous exposure to Microsoft Office packages (including Outlook, Word, and Excel)
• Understanding of medical terminology
• Understanding the importance of and compliance with procedural documents and regulations
• Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision
• Strong attention to detail Ability to maintain a positive and professional demeanor in challenging circumstances
• Ability to work effectively within a team to attain a shared goal