Novartis Medical Safety Lead – MD Job- Apply Now!
Medical Safety Lead – MD
Job ID: REQ-10038256
Location: India / Spain
Job Summary
Novartis is actively seeking a highly skilled Medical Safety Lead – MD to join our Medical Safety organization. In this role, you will play a pivotal part in ensuring patient safety by conducting robust medical evaluations and safety assessments. Working in close collaboration with the Global Program Safety Lead (GPSL), you will drive medical safety innovations and risk assessments throughout the entire product lifecycle. Your expertise will contribute significantly to Novartis’ commitment to patient care, regulatory compliance, and continuous medical advancements.
About the Role
This role is available at two key locations: Hyderabad, India, and Barcelona, Spain. As a Medical Safety Lead, you will be responsible for monitoring, evaluating, and managing clinical safety data. Your contributions will enhance regulatory decision-making, ensure compliance with safety standards, and support Novartis’ broader mission of transforming patient health through innovative solutions.
Major Accountabilities:
- Monitors the clinical safety of projects /products, including activities such as literature review, evaluation of individual cases, or signal detection, and responds to safety-related questions appropriately.
- Performs medical assessment and related activities for cases whenever required, including collecting additional follow-up information as necessary, medical evaluation of product quality defects with adverse events, review of line listings of single cases, and preparation of investigator notifications and periodic medical assessments for ethics committees.
- Identifies safety signals based on the review of solicited or unsolicited single cases.
- Performs signal detection, monitoring, and evaluation of all safety signals.
- Provides inputs into responses to inquiries from regulatory authorities or health care professionals on safety issues.
- Prepares safety data for Health Authority review boards.
- Provides inputs to responses for legal queries and Country Organization requests involving safety issues.
- Provides expert evaluation on the clinical context of adverse event reports, assessment of the medical conditions, and the implications on Novartis products.
- Collaborates productively on clinical safety tasks with colleagues from Clinical Development, Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments.
- Contributes to the development of departmental goals and objectives.
- Distribution of marketing samples (where applicable)
Key performance indicators:
- Timeliness and quality of safety analyses, interpretations, and presentations -Compliance with internal and external regulations and procedures -Compliance, consistency, and quality of safety deliverables.
Minimum Requirements:
- A medical degree (MBBS or MD) is required (specialization preferred).
- 12+ years in drug development, including 6+ years in patient safety at an operational or medical level.
- Strong expertise in clinical trials, regulatory requirements, scientific methodology, and safety assessments.
- Proven ability to analyze and present safety data effectively.
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Keywords: Novartis, Medical Safety Lead, MD, Drug Development, Patient Safety, Healthcare, Clinical Trials, Regulatory Affairs. Novartis Medical Safety Lead – MD Job- Apply Now!
