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), reliable 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 regulatory safety documents.

• Perform medical review and assessment of CIOMS/ICSRs, ensuring medical accuracy, completeness, and compliance with applicable regulatory requirements.

• Support SAE management activities, including follow-up of safety events, medical evaluation, and coordination with investigational sites and pharmacovigilance teams.

• Provide medical oversight for data review activities, including review of listings, trends, safety signals, TLFs (Tables, Listings, and Figures), and medically significant data discrepancies.

• Facilitate interactions with Key Opinion Leaders (KOLs) and Therapeutic Area Experts (TAEs), organize and participate in scientific advisory meetings, and contribute to clinical and scientific discussions.

• Maintain and demonstrate expertise in relevant therapeutic areas and provide ongoing scientific and medical guidance to project teams.

• Collaborate with Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, Pharmacovigilance, and other stakeholders to ensure high-quality study conduct and regulatory compliance.

• Provide medical leadership and support for assigned clinical development projects and undertake additional project-related responsibilities as delegated by management.

📌 Lead - Medical Monitoring & Safety (Hyderabad)
🏢 Dr. Reddy's Laboratories
📍 Hyderabad