Lead - Medical Monitoring & Safety (India)

Dr. Reddy's · India · Refreshed 2 days ago

About this role

Job Description Key Responsibilities: • Review and provide medical oversight for clinical study documents, including Protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), Investigator's Brochures (IBs), and Clinical Modules. • Contribute to the preparation and review of clinical safety narratives, including CSR narratives, regulatory submission narratives, and safety-related medical documents. • Perform medical review of adverse events (AEs), serious adverse events (SAEs), medical coding (MedDRA/WHO Drug), concomitant medications, prior medications, and causality assessments. • Provide medical input into study design and conduct, including CRF review, Medical Monitoring Plans, Protocol Deviation (PD) management, eligibility criteria assessments, laboratory manuals, imaging plans, and other study-specific medical documents. • Support investigator meetings by participating in medical presentations, protocol discussions, and study-specific training activities. • Serve as the primary medical contact for study-related queries from study sites, clinical operations teams, ethics committees (IRBs/IECs), and cross-functional stakeholders. • Conduct protocol and therapeutic area training for internal study teams, investigators, and study personnel to ensure consistent understanding of study requirements. • Review Safety Management Plans, DSURs, PSURs, Risk Management Plans (RMPs), Annual Safety Updates, Medical Review Manuals, and other pharmacovigilance and regulato

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