Senior Medical Safety Expert
Job ID: REQ-10061041
Date Posted: September 25, 2025
Location: Hyderabad, India
Company: Novartis Healthcare Private Limited (IN10)
Division: Development
Business Unit: Innovative Medicines
Functional Area: Research & Development
Job Type: Full-Time | Regular
Shift Work: No
Summary
The Senior Medical Safety Expert is responsible for overseeing drug surveillance programs, including follow-up activities, risk assessment, and product-related adverse reaction evaluations. The role ensures safety oversight across clinical trials and post-marketing programs, supports compliance with global regulations, and contributes to safety signal detection, risk management, and lifecycle safety activities. The incumbent provides expert safety input to clinical development teams and supports responses to regulatory authorities.
Key Responsibilities
Safety Oversight & Signal Management
Monitor product safety profiles through literature review, medical case evaluation, and signal detection.
Conduct risk assessments and ensure appropriate follow-up on adverse reactions.
Support safety signal detection, trending, and risk management throughout the product life cycle.
Regulatory & Clinical Documentation
Co-author safety documents and provide safety input to clinical and regulatory submissions.
Prepare responses to Health Authority (HA) queries and short-notice requests.
Support new indication submissions with regulatory document safety input.
Follow up on Health Authority Assessment Reports and manage local deviations.
Collaboration & Support
Assist Regulatory Affairs and Clinical Development with safety input and documentation.
Prepare responses to internal safety requests and external safety queries.
Act as a Subject Matter Expert (SME) for Medical Operations and Medical Function teams.
Leadership & Mentorship
Lead the training and mentoring of junior team members.
Support knowledge sharing and cross-functional collaboration.
Other Responsibilities
Support distribution of marketing samples (where applicable).
Contribute to maintaining compliance with all internal/external safety regulations.
Key Performance Indicators (KPIs)
Timeliness & Quality: On-time delivery of high-quality safety analyses and reports.
Compliance: Adherence to internal standards, SOPs, and regulatory requirements.
Consistency: Uniform and accurate safety deliverables across functions.
Minimum Requirements
Work Experience
Demonstrated expertise in:
People Management & Crisis Handling
Cross-functional Collaboration
Operational Excellence & Execution
Project Management
Functional Breadth across Safety & Clinical Domains
Technical Skills
Clinical Research & Clinical Trials
Literature Review & Medical Records Analysis
Safety Science & Risk Management
Regulatory Compliance & Process Safety
Cross-functional Team Coordination
Languages
Proficiency in English (required)
Why Novartis?
At Novartis, we believe breakthroughs that change patients’ lives come from passionate people working together. Join a community that collaborates, supports, and inspires each other to create a brighter future for patients around the world.
Learn more: People and Culture
Join Our Network
Not the right role for you? Stay connected with our Talent Community to learn about future opportunities:
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Benefits & Rewards
Explore the full range of ways Novartis supports your personal and professional growth:
📘 Benefits Handbook
Accessibility & Accommodation
Novartis is committed to providing reasonable accommodation to individuals with disabilities.
If you need assistance during the recruitment process or on the job, please email:
📩 diversityandincl.india@novartis.com
Include the Job ID (REQ-10061041) and your contact details.
Inclusion & Diversity
Novartis is dedicated to fostering an inclusive workplace and building diverse teams representative of the patients and communities we serve.
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