Job Title: Medical Safety Lead - MD
Location: Hyderabad, India (also open in Barcelona, Spain)
Employer: Novartis
Job ID: REQ-10038256
Posted: February 10, 2025
Functional Area: Research & Development
Employment Type: Full-time, Regular
Role Overview:
As a Medical Safety Lead - MD at Novartis, you will be responsible for providing robust safety evaluation expertise throughout the lifecycle of projects/products. This role focuses on ensuring the safety of patients through the analysis of clinical safety, signal detection, and risk assessment. You will collaborate closely with various teams and provide medical expertise to improve patient safety for assigned compounds.
Key Responsibilities:
Safety Monitoring:
Monitor the clinical safety of products, including reviewing literature, evaluating individual cases, and conducting signal detection.
Respond to safety-related inquiries from stakeholders and regulatory authorities.
Signal Detection and Medical Assessments:
Identify and evaluate safety signals based on individual case reports.
Perform medical assessment and related activities for adverse events, including follow-up information, medical evaluation of product quality defects, and preparation of investigator notifications.
Collaboration Across Departments:
Work with Clinical Development, Regulatory Affairs, Medical Affairs, Statistics, and other departments to evaluate safety data and make informed decisions.
Prepare safety data for Health Authority review boards and provide expert evaluation on the clinical context of adverse event reports.
Safety Reports and Legal Support:
Provide inputs to responses for legal queries and safety-related requests from Country Organizations.
Contribute to the preparation of safety assessments and regulatory reports.
Key Performance Indicators:
Timeliness and quality of safety analyses and reports.
Compliance with internal and external regulations.
Consistency and quality of safety deliverables.
Minimum Requirements:
Education:
Medical Degree (MBBS or MD) required. Specialization preferred.
Experience:
At least 12 years in drug development, including 6 years in patient safety or a related medical role.
Proven experience in clinical trial methodology, regulatory requirements, scientific methodology, and the preparation of clinical safety assessments and regulatory reports.
Skills:
Strong ability to analyze, interpret, and present safety information.
Expertise in signal detection, medical review, and risk management in drug safety.
Why Novartis?
Novartis is dedicated to improving the lives of patients worldwide. By working with a talented and passionate team, you’ll play a key role in achieving breakthroughs in science and patient care. Novartis fosters an inclusive and collaborative work environment, encouraging employees to innovate and support each other.
Join Novartis:
If you are passionate about advancing patient safety and contributing to groundbreaking medical innovations, this is a great opportunity to join a global leader in healthcare.
Benefits:
Novartis offers competitive benefits to ensure your professional and personal success, focusing on your health, wellness, and career growth.
Apply now to join Novartis and contribute to impactful health innovations.
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