Job Title: Medical Safety Lead - MD
Job ID: REQ-10038256
Location: Hyderabad, India
Company: Novartis Healthcare Private Limited
About the Role
The Medical Safety Lead - MD plays a critical role in ensuring the safety of patients by providing safety evaluation expertise and medical innovation. This position supports the Global Program Safety Lead (GPSL) in managing the safety of clinical products and compounds throughout the product lifecycle. The Medical Safety Lead is responsible for safety analysis, signal detection, and evaluation, and will closely collaborate with various stakeholders, including Clinical Development, Regulatory Affairs, and other departments.
Key Responsibilities
Safety Monitoring and Analysis:
Monitor the clinical safety of projects/products, including literature review, evaluation of individual cases, and signal detection.
Perform medical assessments, including collecting follow-up information, evaluating product quality defects with adverse events, and preparing safety reports.
Signal Detection and Risk Management:
Identify safety signals and contribute to signal detection, monitoring, and evaluation.
Provide inputs into responses for regulatory inquiries, health authorities, and healthcare professionals regarding safety issues.
Collaboration:
Collaborate with colleagues across Clinical Development, Regulatory Affairs, Medical Affairs, and other departments to ensure the optimal safety of clinical trials.
Prepare safety data for Health Authority review boards.
Regulatory Support:
Contribute to responses for regulatory reports, legal queries, and country organization requests involving safety issues.
Ensure compliance with internal and external regulations related to safety.
Leadership and Reporting:
Contribute to the development of departmental goals and objectives.
Provide input for preparing clinical safety assessments and regulatory reports related to safety information.
Key Performance Indicators
Timeliness and quality of safety analyses and interpretations.
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 operational or medical position.
Experience with clinical trial methodology, regulatory requirements, and scientific methodology.
Proven ability to analyze, interpret, and present safety information, both in writing and orally.
Skills:
Experience with safety issue management and the preparation of clinical safety assessments.
Strong communication skills and the ability to work cross-functionally.
Why Novartis?
At Novartis, we’re committed to helping people with diseases live better lives by focusing on medical innovation. By joining Novartis, you’ll become part of a collaborative team that works together to achieve breakthroughs that transform patients’ lives.
Diversity & Inclusion: Novartis fosters an inclusive environment and diverse teams.
Benefits & Rewards: Learn more about the benefits and rewards.
How to Apply
To apply for this role, visit the Novartis Career Portal.
Additional Information
Accessibility: If you require accommodations due to a medical condition or disability, please contact diversityandincl.india@novartis.com.
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