Medical Monitor

Key Responsibilities

• Provide medical oversight for clinical trials across BA/BE and Phase studies
• Review adverse events (AEs), serious adverse events (SAEs), and safety signals
• Draft and review Integrated Summary of Safety and Efficacy (ISS/ISE)
• Prepare and review Medical Monitoring Plans (MMP), Risk Management Plans, REMS and Safety Management Plans
• Support preparation of Investigator’s Brochure, ICF, CSR and regulatory documents
• Perform MedDRA and WHO Drug coding reviews
• Generate and review SAE narratives and safety analyses
• Conduct medical review of protocols and synopses
• Lead site feasibility assessments and prepare SFQs
• Train site and internal teams on protocol and safety procedures
• Coordinate safety communication with stakeholders per ICH-GCP and SOP timelines
• Travel to sites for monitoring activities as required

Core Competencies

• Patient safety oversight and risk-benefit evaluation
• Regulatory and ethical compliance (ICH-GCP, local regulations)
• Cross-functional collaboration with CRAs, statisticians and PV teams
• Real-time data interpretation and safety trend analysis
• High-impact communication and medical decision making
• Protocol deviation detection and corrective action planning

Education & Experience

• MBBS with MD (Pharmacology) – Mandatory
• Foundational to early-career experience in clinical research or pharmacovigilance preferred

Required Skills

• Clinical trial safety monitoring
• SAE / AE medical review
• Regulatory documentation
• MedDRA / WHO-Drug coding
• Data trend analysis
• Investigator communication
• Leadership and mentoring

About Syngene

Syngene International Ltd is an innovation-led Contract Research, Development and Manufacturing Organization (CRDMO) providing integrated scientific services from early discovery to commercial supply. Patient safety, data integrity, and ethical compliance form the core of Syngene’s research culture.