Medical Doctor - Safety

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Job details

Company overview

Our client is a global IT service company that provides a wide range of solutions to help businesses transform their operations, enhance customer engagement, and drive growth in today's digital economy

Responsibilities

• Perform second level triage workflow, review through the entire source document for any potential serious adverse event/s in the case based on conventions
• If the case is serious, then in the activities tab, select the Case level seriousness as Yes
• After the review of the case, document the assessment in the same action item, To be retained as Non-serious OR To be upgraded as Serious with respective rationale and close the action item
• Inform the respective triage associate via email for upgraded case
• Ensuring the ICSR is medically relevant, complete and accurate
• Validation of Seriousness criteria, events captured, coding, labeling, Causality assessment, Writing Company / PV comment. Review and finalize Narratives.
• Generating medically relevant follow-up questions
• Identifying and notifying potential signals

Requirements

Essential Qualification:

• Education: MBBS – (Bachelor of medicine and Bachelor of surgery) and or MD – Doctor of Medicine
• Experience: 4+ years or more of PV medical review of ICSRs experience

Essential skills:

• Native Japanese
• Business level verbal and written skill English Skills
• Proficient in MS office
• Good analytical reasoning skill
• Flexibility/Adaptability/Managing Multiple Priorities
• Operational Responsibilities

Salary

12 - 18 million yen

Location

Tokyo