Medical Safety Expert
Job ID: REQ-10063803
Location: Hyderabad, India
Division: Development
Business Unit: Universal Hierarchy Node
Employment Type: Full-time (CDI)
Shift: No
Summary
The Medical Safety Expert is responsible for monitoring drug safety programs, including:
Review and follow-up of adverse reaction reports
Product risk assessment and relevance
Clinical trial and post-marketing safety surveillance
Compliance with legal and regulatory requirements
The role contributes to signal detection, risk management evaluation across the product lifecycle, and provides safety support to clinical development teams.
Key Responsibilities
Safety Monitoring & Evaluation
Support product safety monitoring, including documentation inspection, medical case evaluation, and signal detection.
Conduct literature reviews and support preparation of specific health authority inquiries, particularly short-notice reporting requests.
Monitor health authority evaluation reports.
Contribute to safe submission of regulatory questions and clinical documents.
Maintain and manage local deviations/anomalies.
Evaluate and prepare assigned safety outputs.
Support new submission guidelines regarding safety documentation.
Respond to internal and external safety requests.
Leadership & Mentorship
Serve as a medical/medical operations expert (MME).
Lead training and onboarding of junior team members or colleagues.
Compliance & Reporting
Ensure adherence to internal and external regulations and procedures.
Maintain safety quality, consistency, and alignment with regulatory requirements.
Support distribution of marketing samples, if applicable.
Key Performance Indicators
Timeliness and quality of safety analysis, interpretation, and reporting
Compliance with regulations and internal/external procedures
Consistency, accuracy, and quality of safety outputs
Required Work Experience
Operations management and execution
Project management
Cross-functional collaboration
Functional breadth
Crisis management and problem-solving
Skills
Clinical research
Process safety
Regulatory compliance
Cross-functional teamwork
Safety science
Literature review
Medical documentation
Clinical trial knowledge
Languages
English
Why Novartis?
Novartis helps people with disease and their families by combining innovative science with a passionate community of professionals. Collaborating, supporting, and inspiring each other drives breakthroughs that change patients’ lives.
Accessibility & Accommodation
Novartis provides reasonable accommodations for individuals with disabilities during recruitment or to perform essential job functions. Contact diversityandincl.india@novartis.com with the job requisition number and details of your request.
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