Medical Officer

Role & Responsibilities
• Lead medical monitoring of clinical trials, providing safety and efficacy oversight throughout the study lifecycle
• Evaluate and review adverse events, serious adverse events (SAEs), and expedited safety reports
• Review SAE narratives, IND/IDE safety reports, CIOMS, DSURs, and other aggregate safety reports
• Review and approve MedDRA and WHO Drug coding
• Provide medical input for protocol development, inclusion/exclusion criteria, and halting rules
• Support development of Safety Monitoring Plans, Medical Monitoring Plans, and training materials
• Participate in safety oversight committees (DSMB/DMC/SMC) and sponsor/investigator meetings
• Support preparation of safety sections for annual reports and clinical study reports
• Act as internal medical consultant for feasibility strategies, bid support, and medical training
• Contribute to audits, SOP development, quality assurance, and corporate safety activities

Qualification
• Medical degree (MD / MBBS / MBBCh or equivalent)

Experience
• Minimum 2 years in clinical practice, pharmaceutical medicine, clinical research, pharmacovigilance, medical affairs, or regulatory domains

Skills
• Strong clinical judgment and safety monitoring expertise
• Knowledge of regulatory submissions and serious adverse event reporting
• Clinical trial data collection and medical monitoring experience
• Excellent scientific communication and leadership skills
• Ability to work effectively in cross-functional and global teams

About the Company
Emmes Group is a global clinical research organization with over 47 years of expertise supporting government and biopharma-sponsored studies. Emmes is a leader in cell and gene therapy, vaccines, rare diseases, neuroscience, and ophthalmology, dedicated to accelerating medical discovery and improving patient lives worldwide.