Location: Hyderabad, India
Division: Development | Business Unit: Innovative Medicines
Company: Novartis Healthcare Private Limited
Job Type: Full-time | Employment Type: Regular
At Novartis, we are committed to improving and extending the lives of patients. To achieve this, we rely on our dedicated team of experts in medical safety who play a crucial role in evaluating and managing the safety of our products. We are currently seeking a Senior Medical Safety Expert to join our team and collaborate closely with the Global Program Safety Lead (GPSL) to provide safety evaluation expertise and drive medical innovation.
As a Senior Medical Safety Expert, you will be responsible for the clinical safety of assigned products throughout the product lifecycle. You will collaborate with various internal teams to ensure that safety evaluations are robust, thorough, and aligned with regulatory and ethical standards.
Safety Monitoring & Evaluation: Monitor clinical safety of assigned projects/products, including activities such as literature reviews, case evaluations, signal detection, and responding to safety-related inquiries.
Medical Assessments: Conduct medical evaluations for adverse event reports, including follow-up information collection, review of product quality defects, and periodic medical assessments for ethics committees.
Signal Detection & Safety Evaluation: Identify and evaluate safety signals from clinical data and adverse event reports. Conduct signal detection and analysis to ensure patient safety.
Regulatory & Legal Inputs: Provide input into responses for regulatory authority queries, healthcare professional inquiries, legal queries, and country organization requests related to safety.
Safety Data for Health Authorities: Prepare and contribute to safety data submissions for health authority review boards, including clinical safety assessments and regulatory reports.
Cross-Functional Collaboration: Collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, Medical Information, Safety Data Management, and other teams to ensure effective safety evaluations and contributions to clinical and regulatory deliverables.
Support for Licensing & Inspections: Provide support for licensing activities, regulatory inspections, and project/product recall activities as needed.
Medical Degree (MBBS or MD) is required; specialization preferred.
At least 12 years of experience in drug development, including 6 years in patient safety (or an equivalent medical position) is desirable.
Proven ability to analyze, interpret, and present safety information both orally and in writing.
Experience in preparing clinical safety assessments and regulatory reports involving safety data.
Experience in drug development, clinical trial methodology, regulatory requirements, and scientific methodology.
At Novartis, we strive to achieve breakthroughs that change patients' lives. Our employees are our greatest asset, and we are committed to fostering a collaborative, innovative, and inclusive work environment. By joining us, you will be part of a team working together to improve global health outcomes.
Novartis is committed to providing reasonable accommodations to individuals with disabilities. If you require assistance during the recruitment process or need accommodations to perform essential job functions, please contact diversityandincl.india@novartis.com.
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