Safety Medicinal Officer

1 week ago

dombivli, India beBeeDrugSafety Full time

Medical Safety PhysicianJob Title:Medical Safety Physician.Required Experience:1-3 years in pharmacovigilance, with a strong understanding of drug safety.Primary Responsibilities:Conduct thorough reviews and assessments of individual case safety reports from clinical trials, spontaneous and solicited reports.Determine regulatory reportability of cases obtained from clinical trials, spontaneous and solicited reports within assigned therapeutic teams and across all products/sites.Perform triage of cases and determine seriousness and relatedness across products as assigned.Review and verify the selection of adverse events from source documents, assign MedDRA codes, assess labeling, and review narrative summaries.Maintain current knowledge of product portfolios and safety profiles for products across therapeutic areas.Evaluate complex case issues on client products and escalate to medical review teams as necessary.Conduct assessments of litigation cases across products as assigned.Identify and resolve case issues, coordinate with client therapeutic teams and functional groups.Communicate effectively within and across all client therapeutic teams and management teams.Maintain knowledge of applicable Global Health Authority regulations.Perform other drug safety-related activities as assigned.Specialized Knowledge and Skills:Experience with relevant safety databases and software applications.Proven ability to handle customer relationships and manage tasks.Excellent people management skills and presentation abilities.Knowledge of the Life Sciences Industry and life cycle of drugs.Relevant product and industry knowledge.Secondary Responsibilities:Strong competence in medical and therapeutic terminology.Understanding of Patient Safety regulatory obligations.Good attention to detail and ability to meet established timelines.Fluency in English and excellent comprehension.

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