Medical Officer – Clinical Trial Monitoring

About the role

Emmes Group is looking for a Medical Officer to lead medical monitoring of clinical trials, ensure safety oversight throughout study lifecycles, and provide expert medical consulting for protocol development and feasibility studies.

Key responsibilities

• Collaborate with the Head of Pharmacovigilance and Medical Monitoring to manage corporate and project‑specific activities.
• Act as the Medical Monitor for assigned protocols, overseeing safety and efficacy data in compliance with SOPs and study documents.
• Provide safety oversight, evaluate adverse events, serious adverse events (SAE) and protocol deviations.
• Review and approve SAE narratives, IND/IDE safety reports, MedWatch alerts, CIOMS reports, DSURs and other aggregate safety documents.
• Ensure accurate MedDRA and WHO Drug coding for regulatory submissions.
• Support bid preparation, medical training delivery, and engagement with external clinical experts.

Required profile

• Proven experience in clinical trial medical monitoring and pharmacovigilance.
• Strong knowledge of regulatory safety reporting requirements (FDA, CIOMS, MedDRA, WHO).
• Ability to work collaboratively with safety monitors, project leaders, data managers and other functional groups.
• Comfortable with hybrid/remote work arrangements in Bengaluru.

Required skills

• MedDRA coding
• WHO Drug coding
• CIOMS safety reporting
• FDA MedWatch reporting
• Adverse event and SAE evaluation