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Content Review Practitioner

0.00 to 1.00 Years   Chennai   19 Jun, 2023
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryEducation / Training
Functional AreaCopywriting
EmploymentTypeFull-time

Job Description

    Content Review PractitionerExp- FresherLocation- ChennaiOnly Female CandidatesShift Night ShiftContract 6 Months (Extendable)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 ReportsConsistent 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 Bachelors degree in Health Sciences; Bachelors Degree in Life Science with relevant Pharmacovigilance experienceKnowledge of medical terminology including knowledge of applicable dictionaries like MedDRA and WHO-DrugGood medical writing skillsGood Communication SkillsAnalytical AbilityStrong English Language proficiency

Keyskills :
meddracontent reviewingcontent writing

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