Medical Safety Physician

Qinecsa Solutions

3 - 7 years

0 Lacs

mysore karnataka

Posted:1 week ago| Platform: Shine logo

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Skills Required

clinical trials meddra drug safety regulatory compliance communication skills medical safety litigation cases

Work Mode

On-site

Job Type

Full Time

Job Description

Role Overview: As a Medical Safety Physician at Qinecsa Solutions India Private Limited, you will play a vital role in reviewing and assessing individual case safety reports from various sources, ensuring regulatory compliance, and communicating effectively within the client therapeutic teams and functional team management. Your responsibilities will include maintaining knowledge of product portfolios, escalating complex case issues, and performing assessments of litigation cases across assigned products. Additionally, you will be required to comply with applicable Global Health Authority regulations and perform other drug safety-related activities as assigned. Key Responsibilities: - Review and assess individual case safety reports from clinical trials, spontaneous and solicited reports. - Determine the regulatory reportability of cases within your assigned therapeutic team and across all products/sites promptly. - Perform triage of cases, assess seriousness and relatedness, assign appropriate MedDRA codes, review narratives, and assess labeling. - Maintain current knowledge of the product portfolio and safety profiles across therapeutic areas. - Escalate complex case issues to the medical review team when necessary. - Conduct assessments of litigation cases across assigned products. - Communicate effectively within client therapeutic teams and functional team management. - Comply with applicable Global Health Authority regulations. - Perform other drug safety-related activities as assigned. Qualifications Required: - Educational qualifications in a relevant field. - Industry experience. - Specific certifications. (Note: Additional details of the company were not included in the provided job description),

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Qinecsa Solutions

Pharmaceutical Manufacturing

London England

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Medical Safety Physician