Pharmacovigilance Physician

• Provide medical oversight of pharmacovigilance activities and ensure compliance with SOPs, client directives, GCP, and regulatory requirements
• Attend and present at sponsor meetings
• Provide medical and pharmacovigilance consultation to clients and project team members
• Support business development activities as needed
• Manage medical aspects of contracted pharmacovigilance tasks across the pharmaceutical product life cycle
• Provide therapeutic and protocol training on assigned studies
• Write and/or review safety sections of CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, and CTD modules
• Scientifically review aggregate reports, contribute to label updates, assess literature, and support dossier maintenance and risk management activities
• Medically review cases, adverse events of special interest, and serious adverse events
• Perform data reviews and validate coding listings or full safety data to identify potential safety concerns
• Review adverse event and serious adverse event data from solicited, spontaneous, and literature sources
• Identify and investigate safety signals and contribute to management of assigned products’ benefit-risk profiles

• Must be MD or equivalent or MBBS qualified graduate
• 5+ years of experience in the pharmaceutical/biotech industry, including at least 2 years in pharmacovigilance/drug safety
• Experience in clinical practice or academic medicine is a plus
• Working knowledge of pharmacovigilance regulatory requirements and guidance documents
• Ability to perform medical assessments of safety data from multiple sources
• Experience authoring complex documents and contributing to regulatory submissions
• Knowledge of adverse event reporting systems
• Experience in epidemiology, biostatistics, clinical development, or medical affairs is a plus
• At least 2+ years of experience in pharmacovigilance medical review activities
• Clinical expertise with attention to detail, quality, and patient safety
• Excellent medical knowledge of physiology and pharmacology
• Understanding of clinical study objectives and the complete drug development process
• Technical, analytical, organizational, problem-solving, multitasking, communication, and presentation skills
• Ability to work independently and under pressure and prioritize sensitive, complex information
• Proficiency in basic computer applications
• Fluent spoken and written English
• Excellent interpersonal, influencing, and team-building skills
• Good understanding of FDA, ICH, EMA, and GCP guidelines
• Working knowledge of safety databases, MedDRA, biostatistics, data management, and clinical operations procedures
• Ability to mentor and train other staff

• Global team environment
• Career development opportunities
• Collaboration and professional development
• Meaningful work contributing to health outcomes
• Occasional domestic and international travel opportunities