Medical Safety Physician
Qinecsa Solutions Pvt. Ltd.
Total years of experience :2 years, 1 Months
• Conduct review and assessment of ICSRs obtained and route the cases to approval activity.
• Perform triage of cases and determine seriousness and relatedness across products as assigned.
• Review and verify appropriate selection of AE from source documents, assign appropriate MedDRA code, assess labelling, review narrative and provide the company comment in accordance with client requirements.
• Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic area.
• Escalate complex case issues on client products to Project manager as appropriate.
• Identity and resolve case issues, coordinate with client therapeutic teams.
• Appropriately assess case severity inorder to prioritise follow-up.
• Conducts training internally for other staffs and Drug safety associates.
• Carefully reviews and documents Regulatory agency requests.
• Submit ICSRs, ADRs, PSUR files to the Healthcare Authorities.
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