Qualifications:

• Experience in Intake/Triage, Data Entry, Quality Review, Case Finalization/Distribution of cases
• Received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and
Clinical trials.
• Experience in raising follow-up queries, as necessary, with appropriate documentation in the
safety database.
• Experience in ARGUS database is good to have.
• Experience in rare disease portfolio is an advantage
• Must possess basic knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other
regulatory requirements.
• Translation of Chinese safety reports and documents to English Safety reports and documents.

Requirements:

Bachelor’s or master’s in pharmacy / Life Sciences or above and in alignment with project / business team requirements.

Proficient in English and Mandarin languages, both oral and written.

Minimum of 1-3 years of relevant experience in identified functional domain/ business workstream.

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Mandarin Speaking Data Entry Specialist

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