Medical Risk Specialist

2 days ago

vadodara, India beBeeMedical Full time

Job DescriptionWe are seeking experienced medical professionals to assume key roles in Medical Safety Physician positions.Key Responsibilities:Review and assess individual case safety reports from clinical trials, spontaneous and solicited reports.Determine regulatory reportability of cases within assigned therapeutic teams and across all products/sites.Perform triage of cases and determine seriousness and relatedness across products.Review and verify adverse events from source documents, assign MedDRA codes, assess labeling, and review narrative.Acquire and maintain knowledge of product portfolios and safety profiles for products across therapeutic areas.Escalate complex case issues to the medical review team as necessary.Conduct assessments of litigation cases across products.Identify and resolve case issues, coordinate with client therapeutic teams/site for specific products or functional groups.Required Skills and Qualifications:MBBS/MD degree.Mandatory MCI registration/state medical council registration.1-3 years of experience in Pharmacovigilance.Strong competence in medical and therapeutic terminology.Understanding of Patient Safety regulatory obligations.Good attention to detail and ability to deliver within established timelines.Fluency in spoken and written English.

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