Location: Hyderabad
Job ID: REQ 10015609
Business Unit: Innovative Medicines
Functional Area: Research & Development
End Date for Applications: 30th October 2024
Company Overview:
At Novartis, we are dedicated to transforming the lives of patients through innovative medicines. Our diverse and talented teams are driven by a shared commitment to improving health outcomes. Join us and be part of one of the most rewarding employers in the pharmaceutical industry!
Position Summary:
We are seeking a Medical Safety Lead to join our Medical Safety organization. In close collaboration with the Global Program Safety Lead (GPSL), you will provide robust safety evaluation expertise and contribute to medical innovation aimed at enhancing patient lives. Your work will be crucial in ensuring optimal patient safety for assigned compounds and in the analysis and evaluation of safety information throughout the product lifecycle.
Key Responsibilities:
- Monitor clinical safety of projects/products through literature reviews, individual case evaluations, and signal detection.
- Conduct medical assessments for adverse events, including follow-ups and evaluations related to product quality defects.
- Identify and evaluate safety signals from solicited and unsolicited case reviews.
- Prepare safety data for Health Authority review boards and respond to inquiries from regulatory authorities and healthcare professionals.
- Collaborate with cross-functional teams (Clinical Development, Regulatory Affairs, Medical Affairs, etc.) on clinical safety tasks.
- Provide safety inputs for clinical and regulatory deliverables, including study protocols and reports.
- Support licensing activities, regulatory inspections, and project/product recall initiatives as needed.
Candidate Profile:
- Education: Bachelor of Science in Pharmacy, Nursing, PharmD, PhD in relevant field, or a Medical Degree (MBBS/MD). A specialized medical degree is preferred.
- Experience: Minimum of 12 years in drug development in a major pharmaceutical company, including 6 years in patient safety. Relevant clinical or postdoctoral experience is highly desirable.
- Strong knowledge of drug development, clinical trial methodology, regulatory requirements, and scientific methodologies.
- Proven ability to analyze, interpret, and present safety information effectively in both written and oral formats.
- Experience in preparing clinical safety assessments and regulatory reports.
Why Novartis?
Join Novartis and be part of a team that is dedicated to innovation and improving patient outcomes. We offer a dynamic work environment, opportunities for professional growth, and a commitment to diversity and inclusion.
Apply Now:
If you are passionate about patient safety and ready to make an impact in the pharmaceutical industry, we encourage you to apply by 30th October 2024.