Case Processing - QR

Primary Responsibilities:

• Experience in Intake/Triage, Data Entry, Quality Review, Case Finalization/Distribution of cases received from sources such as Legal case, 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.
• Experience in rare disease portfolio.
• Must possess thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements.
• Training and mentoring skill (ICSR, Safety database etc)

Qualifications and desired skills:

• Masters in science or above and in alignment with project / business team requirements.
• Minimum of 2 years of experience in QR workflow and an overall experience in ICSR
• Must have hands on experience with MS office applications (Outlook, Excel, Word, Power Point etc)