Medical Monitoring Jobs at Dr Reddy’s
A rare chance has emerged for qualified medical professionals to step into the role of Lead Medical Monitoring & Safety at Dr Reddy’s Laboratories. The Medical Monitoring Jobs at Dr Reddy’s require an MBBS and MD with 2–4 years of experience in Clinical Development or Biologics, focusing on medical oversight of protocols and related activities.
About Dr Reddy’s Laboratories:
Dr Reddy’s Laboratories is a global pharmaceutical company based in India, dedicated to providing affordable and innovative medicines for various health conditions. The organization operates in multiple therapeutic areas, including oncology, cardiology, and diabetes, and is committed to high-quality standards in drug development and manufacturing. With a strong presence in both domestic and international markets, Dr Reddy’s aims to improve access to healthcare through its diverse portfolio of products.
Job Details:
- Position: Lead Medical Monitoring & Safety
- Job Type: Full-time
- Job Family: Clinical Development
- Sub Job Family: Clinical Design
- Business unit: Biologics
- Location: Hyderabad, India
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 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 in the Non-Clinical Job.
- Provide medical leadership and support for assigned clinical development projects and undertake additional project-related responsibilities as delegated by management.
Qualifications Required for the Medical Monitoring Jobs:
- MBBS with M.D. Pharmacology/Medicine or full-time post-graduate qualification in any discipline of medicine
- 2-4 years of experience in the pharmaceutical industry or research company in a Medical Advisor capacity
Knowledge & Skills Required:
- Experience in clinical research, medical monitoring, pharmacovigilance, medical affairs, or clinical development preferred.
- Strong understanding of ICH-GCP, CDSCO, FDA, EMA, and other applicable regulatory requirements.
- Experience in protocol review, medical data review, safety assessment, and medical monitoring activities.
- Knowledge of adverse event evaluation, medical coding (MedDRA/WHO Drug), and safety reporting requirements.
- Excellent scientific writing, presentation, and communication skills.
- Ability to work effectively in cross-functional and matrix team environments.
- Strong analytical, medical judgment, and problem-solving skills.
- Therapeutic area expertise in relevant disease areas will be an added advantage.
Behavioural Skills Required for the Medical Monitoring Jobs:
- Integrity-driven decision-making skills.
- Sound scientific knowledge.
- Collaboration and teaming with the ability to work in a matrix environment.
- Strategic thinking & sound analytical skills.
- Intellectual curiosity.
- Self-awareness and adaptability to work in a matrix environment.
- Result-oriented and performance-driven.
- Excellent interpersonal & communication skills to effectively interact with a broad range of audiences.
