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

customer handling people management presentation skills product knowledge meddra coding task management life sciences industry drug life cycle global health authority regulations

Work Mode

On-site

Job Type

Full Time

Job Description

As a Medical Safety Physician at Qinecsa Solutions India Private Limited, you will be responsible for reviewing and assessing individual case safety reports obtained from clinical trials, spontaneous and solicited reports. You will determine the regulatory reportability of cases within your assigned therapeutic team and across all products/sites in a timely manner. Your role will involve performing triage of cases, determining seriousness and relatedness, assigning appropriate MedDRA codes, assessing labeling, and reviewing narratives. It is essential to maintain current knowledge of the product portfolio and safety profiles across therapeutic areas. You will escalate complex case issues to the medical review team when necessary and conduct assessments of litigation cases across assigned products. Effective communication and interaction within client therapeutic teams and functional team management are crucial aspects of this role. Additionally, you will be required to comply with applicable Global Health Authority regulations and perform other drug safety-related activities as assigned. In this position, you are expected to contribute to a team environment with professionalism and skill, demonstrating flexibility in a dynamic, fast-paced, cross-functional setting. The ability to manage multiple tasks concurrently and deliver results under stringent timelines is essential for success in this role. Educational qualifications in a relevant field, along with industry experience and specific certifications, are preferred. Key performance indicators, competencies, knowledge, skills, and abilities required for this role will be outlined to ensure your success as a Medical Safety Physician. The work environment may involve travel, and other specific requirements such as vehicle usage, work permits, contract types, time constraints, compliance-related aspects, and union affiliation will be detailed as per the company's policies and regulations.,

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Qinecsa Solutions

Pharmaceutical Manufacturing

London England

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Medical Safety Physician