Medical Doctor - Safety

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Job details

Company overview

We are a global IT services and consulting company that supports business transformation through digital, technology, and consulting services. We provide digital strategy, IT consulting, systems integration, and outsourcing services, aiming to drive industry innovation and efficiency. Additionally, we leverage our global network and advanced technologies to deliver optimal solutions to our clients.

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