Medical Safety Specialist

5 days ago


kollam, India beBeePharmacovigilance Full time

Job OverviewWe are seeking an experienced Medical Safety Physician to join our team. This role involves conducting reviews and assessments of individual case safety reports, determining regulatory reportability of cases, and performing triage of cases.The ideal candidate will have 1-3 years of experience in Pharmacovigilance and be able to conduct review and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reports.Key Responsibilities:Case Review and Assessment: Conduct thorough review and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reports.Regulatory Reportability: Determine regulatory reportability of cases within assigned therapeutic team and across all products/sites, as necessary, and in a timely fashion.Clinical Triage: Perform triage of cases and determine seriousness and relatedness across products as assigned.Event Management: Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labeling, review narrative.Product Knowledge: Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas.Requirements:Safety Database Experience: Experience with relevant safety databases and related software applications.Customer Handling: Proven experience in customer handling and relationship.Task Management: Proven ability to perform task management.People Management: Proven people management skills.Presentation Skills: Must have good presentation skills and the ability to give presentations.This is an exciting opportunity for a dedicated professional to contribute to the success of our organization.



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