Job Description
Primary Responsibilities:
Perform Intake/Triage, Data Entry, and Quality Review for individual case safety reports from a variety of sources, including spontaneous, literature, regulatory, and clinical trial cases.
Manage case finalization and distribution, ensuring timely and accurate submission.
Raise follow-up queries as needed and maintain complete documentation in the safety database.
Candidate Profile:
Bachelor's or Master's in Pharmacy / Life Sciences or above and in alignment with project / business team requirements.
Must have hands-on experience with MS office applications (Outlook, Excel, Word, Power Point etc.).
Must possess knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements.
Training and mentoring skills(ICSR, Safety database etc.).
Fresh graduates are welcome to apply.
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Perform Intake/Triage, Data Entry, and Quality Review for individual case safety reports from a variety of sources, including spontaneous, literature, regulatory, and clinical trial cases.
Manage case finalization and distribution, ensuring timely and accurate submission.
Raise follow-up queries as needed and maintain complete documentation in the safety database.
Candidate Profile:
Bachelor's or Master's in Pharmacy / Life Sciences or above and in alignment with project / business team requirements.
Must have hands-on experience with MS office applications (Outlook, Excel, Word, Power Point etc.).
Must possess knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements.
Training and mentoring skills(ICSR, Safety database etc.).
Fresh graduates are welcome to apply.
Show more Show less
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