Patient Safety Physician

đŸ”„ 0 minutes ago

🇼🇳 India – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

đŸ‘» Ghost score 10%

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Logo of Parexel

Parexel

10,000+ employees

Founded 1983

đŸ’Œ Consulting

đŸ„ Healthcare

📩 Logistics

💰 Venture Round on 1990-01

Consulting ‱ Healthcare ‱ Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

‱ Perform medical review of spontaneous, clinical trial, literature, and combination product adverse event cases ‱ Assess seriousness, expectedness, listedness, causality, and overall medical relevance of reported safety events ‱ Review narratives, medical coding, source documentation, and case content for medical accuracy and consistency ‱ Provide medical guidance and support to pharmacovigilance and safety operations teams during case processing ‱ Support medical monitoring through review of adverse events, patient profiles, laboratory data, vital signs, medical history, and concomitant medications ‱ Provide medical and scientific input to internal teams, clients, investigators, and study personnel under appropriate supervision ‱ Review scientific and medical literature for product safety assessments and potential safety concerns ‱ Participate in internal and external meetings and present safety-related information ‱ Maintain awareness of global drug safety regulations, reporting obligations, and pharmacovigilance requirements ‱ Collaborate with stakeholders to address safety-related issues and support project objectives

🎯 Requirements

‱ Bachelor of Medicine, Bachelor of Surgery (MBBS), Doctor of Medicine (MD), or equivalent medical qualification from an accredited medical school ‱ Completion of basic clinical medicine training, including residency, internship, or equivalent ‱ Fresher or relevant experience in pharmacovigilance, drug safety, clinical practice, or medical data review activities ‱ Knowledge of medical terminology and clinical assessment principles ‱ Understanding of ICH-GCP, GVP, global drug safety regulations, and applicable pharmacovigilance guidelines ‱ Strong communication, organization, analytical, and problem-solving skills ‱ Computer proficiency, including experience with Microsoft Office applications and web-based systems ‱ Experience working in clinical medicine, pharmacovigilance, clinical research, or a regulated healthcare environment ‱ Comfort working with safety databases, web-based applications, Microsoft Office tools, and pharmacovigilance processes

đŸ–ïž Benefits

‱ Continuous learning opportunities ‱ Diverse teams and growth-oriented environment ‱ Remote work arrangement

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