Medical Safety Physician

Role & Responsibilities
• Conduct review and assessment of individual case safety reports (ICSRs) obtained from clinical trials, spontaneous, and solicited reports
• Determine regulatory reportability of cases within assigned therapeutic teams and across all products/sites
• Perform triage of cases and assess seriousness and relatedness across products
• Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA codes, and assess labeling
• Review and write narratives for ICSR
• Acquire and maintain current knowledge of product portfolio and safety profiles across therapeutic areas
• Escalate complex case issues to the medical review team of the client as needed
• Conduct assessment of litigation cases across products as assigned
• Identify and resolve case issues, coordinating with client therapeutic teams and functional groups
• Communicate effectively within and across client therapeutic teams and functional management
• Maintain knowledge of applicable Global Health Authority regulations and drug safety standards
• Perform other drug safety related activities as assigned

Qualification
• MBBS or MD
• Mandatory: MCI Registration/State Medical Council Registration

Experience
• 1 - 3 years of relevant experience in Pharmacovigilance, specifically as a Medical Reviewer

Skills
• Experience with relevant safety databases and related software applications
• Proven customer handling and relationship management skills
• Task management and ability to deliver within established timelines
• Strong presentation skills with the ability to deliver clear and engaging presentations
• Knowledge of the Life Sciences Industry and lifecycle of drug development
• Strong competence in medical and therapeutic terminology
• Understanding of Patient Safety regulatory obligations
• High attention to detail
• Proficiency in spoken and written English with excellent comprehension

About The Company
• Qinecsa Solutions – A leading provider of pharmacovigilance and drug safety services. Qinecsa Solutions specializes in offering comprehensive drug safety and medical review services for global pharmaceutical companies.