Roles and Responsibilities o Review and verification of appropriate sections of adverse events, appropriate MedDRA coding, labelling, causality and provide a medical assessment comment as needed for ICSR.
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Reviews medical content and quality of the Case and ensures that all events from the source documents are accurately coded and verify consistency between source documents and narrative summary. o Actively follow up of adverse events to obtain more information and review of all letters and queries for appropriateness and completeness. Start an Ad-hoc follow-up whenever required. o Constantly update domain and operations skills as per the changing Regulatory requirements by reading the updated version of SOP.
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Route the Case to Distribution and ensure the case is locked. o Provide feedback for the Case creation and data entry production leads about the quality of data entry in serious cases. o Actively involved in case discussion with client and provide the valuable inputs to the team. o Offline peer review of agreed sample of Cases for assessment of quality of narrative, E2B sender’s comment and medical query completeness o To participate in audits or inspections. o Training and mentoring of new associates. o Authoring of process documentso Drug safety related activities.
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Desired Profile: –• Adaptable and flexible • Quick learner and a team player • Minimum of medical degree (MBBS). Medical degree with higher speciality preferred. • Min. 2 to 5 years of experience (in ICSR medical review).• In-depth knowledge of medical terminology • Good Communication Skills, medical writing skills and Analytical Ability • Strong English Language proficiency
