Title Medical Safety Physician

2 - 6 years

0 Lacs

Posted:1 week ago| Platform: Shine logo

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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 conducting review and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reports. You will determine the regulatory reportability of cases within assigned therapeutic team and across all products/sites in a timely manner. Your role will involve performing triage of cases, determining seriousness, relatedness, and assigning appropriate MedDRA codes. Additionally, you will review narratives, assess labeling, and escalate complex case issues to the medical review team when necessary. You must have experience with relevant safety databases and software applications, along with proven customer handling and relationship skills. Task management and people management capabilities are essential for this role. Your presentation skills will be put to use as you communicate effectively within and across client therapeutic teams. It is important to have knowledge of the Life Sciences Industry, drug life cycles, and relevant product and industry information. In this position, you will acquire and maintain current knowledge of product portfolios and safety profiles across therapeutic areas. You will be responsible for identifying and resolving case issues, coordinating with client therapeutic teams, and adhering to applicable Global Health Authority regulations. Moreover, you may be required to contribute to a team environment, demonstrate flexibility, and complete multiple tasks concurrently under stringent timelines. The ideal candidate for this role should possess a relevant educational background, required certifications, and industry experience. Key performance indicators, competencies, knowledge, skills, and abilities play a crucial role in ensuring success in this position. Understanding work environment details, specific requirements, and other job-related information will be essential for carrying out the responsibilities effectively. In summary, as a Medical Safety Physician at Qinecsa Solutions India Private Limited, you will play a vital role in ensuring the safety and regulatory compliance of products across therapeutic areas while effectively managing case reviews, communication with clients, and maintaining knowledge of industry regulations and standards.,

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Qinecsa Solutions logo
Qinecsa Solutions

Pharmaceutical Manufacturing

London England

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