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 in a timely manner
• Perform triage of cases and assess seriousness and relatedness across products
• Review and verify appropriate selection of adverse events from source documents, assign MedDRA codes, assess labeling, and review narratives
• 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 necessary
• Conduct assessment of litigation cases across products
• Identify and resolve case issues, and coordinate with client therapeutic teams or functional groups
• Communicate effectively within and across all client therapeutic teams, and within functional management
• Maintain knowledge of applicable Global Health Authority regulations
• Perform additional drug safety-related activities as assigned

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

Experience
• 1 - 3 years in Pharmacovigilance or related medical review experience

Skills
• Experience with relevant safety databases and related software applications
• Proven customer handling and relationship management skills
• Strong task management and ability to deliver within established timelines
• Excellent presentation and communication skills, both verbal and written
• Knowledge of the Life Sciences industry and the drug development lifecycle
• Familiarity with medical and therapeutic terminology
• Understanding of Patient Safety regulatory obligations
• High attention to detail

About The Company
• Qinecsa Solutions – A leading provider of pharmacovigilance and drug safety services, specializing in the evaluation and management of drug safety for pharmaceutical companies globally.