2coms
Location
Bangalore South | India
Job description
Prioritize case processing activities for ICSRs in
accordance with project guidelines, Regulatory due date and TAT SLAs and KPIs. • Processing and evaluation of
Individual Case Safety Reports • Consistent data entry and processing from source documents, adhering to
timelines and quality. • Confirm accurate and consistent coding of medical history, drugs and adverse event terms.
• Assess adverse event reports for seriousness, causality and expectedness as per applicable labeling, consulting
the Medical Reviewer whenever needed. • Alert the Medical Reviewer of potential safety issues and assist the
Medical Reviewer in monitoring the safety profile of product as appropriate. • Determine if any additional
information is needed for clarification, or if any follow-up is necessary, and take all relevant steps to obtain any
additional/missing information as stated in the relevant Project SOP. • Archive all communications/clarifications
related to the Case in the Global Safety Database. • Initiate and handle case deletions/ nullification as appropriate.
• To participate in audits or inspections. • Open to get trained and moved across roles based on business
requirement. • Training and mentoring to new associates. • Authoring of process documents. • Minimum of
Bachelor’s degree in Health Sciences ; Bachelor’s Degree in Life Science with relevant Pharmacovigilance experience
• Knowledge of medical terminology including knowledge of applicable dictionaries like MedDRA and WHO-Drug •
Good medical writing skills • Good Communication Skills • Analytical Ability • Strong English Language proficiency
• Minimum of Master’s degree in Life Sciences ; Bachelor’s Degree in Life Science with
relevant Pharmacovigilance experience • Knowledge of medical terminology including knowledge of applicable
dictionaries like MedDRA and WHO-Drug • Good medical writing skills • Good Communication Skills • Analytical
Ability • Strong English Language proficiency
** Candidate communication and Stable resource needed with Good Communication (Strictly)**
Salary – 23000/-
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