Medical Officer

Role & Responsibilities
• Perform medical monitoring of clinical trials, ensuring safety and efficacy data are managed in accordance with protocols
• Lead safety oversight throughout the clinical study lifecycle, including evaluation and monitoring of adverse events (AEs) and serious adverse events (SAEs)
• Review safety reports, including SAE narratives, CIOMS reports, MedWatch reports, and aggregate reports
• Provide medical input during protocol development, ensuring safety aspects are covered
• Advise study sponsors and teams on inclusion/exclusion criteria, eligibility, protocol design, and halting rules
• Collaborate with Safety Monitors to implement safety management activities and achieve study objectives
• Participate in safety oversight committees and consult with sponsors, investigators, and pharmaceutical partners
• Engage in bid preparation, bid defense meetings, and other business development activities
• Participate in regulatory meetings and provide medical consultancy services for various documents

Qualification
• MD, MBBS, MBBCh, or equivalent medical degree

Experience
• Minimum of 2 years of experience in clinical practice or pharmaceutical medicine (clinical research, pharmacovigilance, medical affairs, regulatory)
• Experience in safety monitoring, medical review, and serious adverse event reporting preferred
• Demonstrated expertise in clinical trial data collection and regulatory submissions

Skills
• Excellent clinical judgment and the ability to communicate complex clinical issues
• Strong leadership and teamwork skills to foster a positive, cross-functional work environment
• Ability to direct activities and provide creative solutions in a medical setting
• Proficient in verbal and written communication skills

About the Company
• Emmes Group is a global leader in clinical research, dedicated to advancing medical discoveries with expertise in clinical trials, safety monitoring, and regulatory compliance.