Medical Safety Physician
Qinecsa Solutions
We are Hiring Medical Safety Physicians/Drug Safety Physicians with 1-3 years of relevant experience as a Medical Reviewer. Job Title: Medical Safety Physician Qualifications Education: MBBS / MD Mandatory: MCI Registration/State Medical Council Registration Experience: 1 - 3 years in Pharmacovigilance Primary Responsibilities As a medical reviewer Conduct review and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reports Determine regulatory reportability of cases obtained from clinical trials, spontaneous and solicited reports within assigned therapeutic team and across all products/sites, as necessary, and in a timely fashion Perform triage of cases and determine seriousness and relatedness across products as assigned Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labeling, review narrative. Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas Escalate complex case issues on client product(s) to the medical review team of the client as appropriate Conduct assessment of litigation cases across products as assigned Identify and resolve case issues, coordinate with client therapeutic teams/site for specific products or functional groups Communicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriate Acquire and maintain knowledge of applicable Global Health Authority regulations Perform any other drug safety related activities as assigned. Specialized knowledge and skills : Experience with relevant safety databases and related so
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