Dear Pharma Aspirants,
Here is a one more Job Openings Update for Experienced Candidates…
Sojar Research Services Pvt. Ltd. is hiring for the role of ICSR Medical reviewer
Qualification: MBBS Physician (MCI registered)
Experience: 3-7 years of ICSR experience required
Responsibilities:
• Responsible for medical review of ICSRs for accuracy, medical relevance, and overall consistency of information captured in the safety database against all the applicable supporting documents as per the client requirement
• Medical evaluation of adverse event reports, including but not limited to all serious and expedited reports and all pregnancy reports.
• Evaluate adverse event report for seriousness, listedness, corrects coding of the adverse event and ensures that all medically relevant information from the source documents is included and provide causality assessment.
• Perform final check of the case and provide medical sign off on the case.
• Confirm and rectify coding of events and terms in other fields, ranking of events, assessment of seriousness criteria and listedness/expectedness
• Ensure appropriate follow-up questions/questionnaires are sent out based on the case.
• Medical Review and oversight of ICSRs and literature surveillance as a part of pharmacovigilance activities and for aggregate reports for the purpose of expedited/periodic submission as per the Regulations and SOPs.
• Tracking of inconsistencies on activities performed by data entry and QC reviewer as per the checklist and provide the feedback to QC team as learnings activities as per client requirement and agreed standards.
• Work and interact extensively with relevant stakeholders to ensure high quality regarding scientific content, organization, clarity, accuracy, format and adherence to regulatory and internal guidelines, styles and processes.
• Responsible for following international pharmacovigilance regulations, company and department SOPs and department and function working practices.
Interested candidates share your CV at: hr@sojarresearch.com
SOURCE: LinkedIn
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