Lead - Medical Monitoring & Safety at Dr Reddy's Laboratories Limited

Job Details at a Glance Location Hyderabad, Telangana, India Company Dr Reddy's Laboratories Limited Experience 2-4 years Qualification 24 years. Hands-on with GCP. Relevant technical / engineering background Eligible Batch 2023, 2024, 2025, 2026 Job Type Full Time Salary Not Disclosed Industry Healthcare Key Skills Medical Review of Adverse Events Clinical Study Document Review GCP Compliance Regulatory Submission Narratives Medical Coding (MedDRA) Lead - Medical Monitoring & Safety at Dr Reddy's Laboratories Limited Full Details & How to Apply Dr Reddy's Laboratories Limited is seeking a Lead - Medical Monitoring & Safety to oversee medical review of adverse events in Hyderabad, Telangana, India . This role is pivotal for ensuring GCP compliance and regulatory submission narratives in clinical trials. The Lead - Medical Monitoring & Safety role is critical in the healthcare industry as pharmaceutical companies increasingly prioritize safety and compliance. Dr Reddy's Laboratories Limited is expanding its global footprint, making this role a key player in maintaining high standards in clinical research. Dr Reddy's Laboratories Limited stands out for its robust presence in the pharmaceutical sector and commitment to innovation. The companys focus on quality and regulatory compliance aligns perfectly with the requirements of the Lead - Medical Monitoring & Safety role, offering a stable and growth-oriented environment. 2023, 2024, 2025, 2026 graduates with 24 years. Hands-on with GCP. Relevant technical / engineering background and 2-4 years experience are eligible. The salary is Not Disclosed , but the role offers significant professional development and exposure to global clinical trials. This role involves working with Medical Review of Adverse Events , Clinical Study Document Review , GCP Compliance , Regulatory Submission Narratives , and Medical Coding (MedDRA) . It provides a clear path for career advancement in the pharmaceutical industry, with opportunities to lead complex projects and influence regulatory strategies. Role Difficulty: Medium | Competition Level: Medium | Fresher Friendly: Yes NexisGrow.com features this opportunity as part of its curated non-tech job listings. All details are sourced from the official job posting. Apply online before the opportunity closes. Job Role & Responsibilities The core mission of the Lead - Medical Monitoring & Safety at Dr Reddy's Laboratories Limited is to ensure compliance with GCP while overseeing the safety of clinical trials and managing adverse event reports. Conduct medical review of adverse events to ensure accurate documentation and compliance with GCP standards. Review clinical study documents to verify adherence to regulatory requirements and internal protocols. Prepare regulatory submission narratives that clearly articulate findings and ensure alignment with GCP guidelines. Utilize MedDRA for medical coding of adverse events to facilitate accurate reporting and analysis. Collaborate with cross-functional teams to ensure timely resolution of safety issues identified during clinical trials. Monitor compliance metrics to identify trends and implement corrective actions as necessary. Provide training on GCP compliance to team members and stakeholders to enhance overall understanding and adherence. This role fosters a culture of ownership, allowing you to directly impact the safety and efficacy of clinical trials at Dr Reddy's Laboratories Limited . Required Skills & Technical Competencies The ideal candidate will possess a robust skill profile focused on medical monitoring and GCP compliance to effectively manage clinical trial safety. Technical Skills Medical Review of Adverse Events advanced Conduct thorough evaluations of adverse events to ensure compliance with regulatory standards. Clinical Study Document Review intermediate Assess clinical study documents for accuracy and adherence to GCP guidelines. GCP Compliance advanced Ensure all clinical activities align with GCP regulations to maintain trial integrity. Regulatory Submission Narratives intermediate Develop comprehensive narratives for regulatory submissions that reflect clinical findings. Medical Coding (MedDRA) intermediate Apply MedDRA coding for accurate classification of adverse events in clinical trials. When showcasing these technical skills in your resume or interview, emphasize specific experiences and outcomes related to each skill to demonstrate your expertise. Eligibility Criteria This role is designed for candidates with a strong technical background in healthcare and relevant experience in clinical safety. Bachelor's or Master's degree in a relevant field such as Life Sciences or Engineering. Eligible batches include 2023, 2024, 2025, and 2026 . 2-4 years of hands-on experience with GCP in a clinical setting. A minimum CGPA of 3.0 on a 4.0 scale is preferred. Portfolio demonstrating experience in medical review a