Medical Safety Lead
Company: Novartis
Job ID: REQ-10077883
Department: Development
Functional Area: Research & Development
Location: Hyderabad
Work Model: Hybrid (12 days/month in office)
Employment Type: Full-time, Regular
Posted Date: 22 May 2026
Job Summary
The Medical Safety Lead role at Novartis focuses on evaluating clinical safety data, managing pharmacovigilance activities, detecting safety signals, and supporting regulatory safety processes across the product lifecycle. The role combines scientific expertise, clinical interpretation, and cross-functional collaboration to ensure patient safety and support global drug development programs.
The position also emphasizes innovation through AI-enabled pharmacovigilance and safety process improvements.
Key Responsibilities
1. Clinical Safety Monitoring
Monitor and evaluate clinical safety data from:
Literature sources
Adverse event case reports
Signal detection activities
Aggregate safety data
Conduct medical assessment of individual adverse event cases.
Ensure accurate interpretation and evaluation of clinical safety information.
2. Signal Detection & Safety Evaluation
Identify, evaluate, and monitor safety signals using:
Single-case reports
Aggregate datasets
Safety trend analyses
Guide:
Causality assessment
Adverse event coding
Clinical interpretation of safety findings
Support management of emerging safety concerns and risk escalations.
3. Regulatory & Safety Documentation Support
Contribute to preparation of:
Aggregate safety reports
Clinical overviews
Regulatory submission documents
Safety summary reports
Support responses to:
Regulatory authority queries
Healthcare professional safety inquiries
Assist with:
Labeling updates
Compliance-related activities
Safety issue management
4. AI & Pharmacovigilance Innovation
Drive implementation of AI-enabled solutions to improve pharmacovigilance processes.
Utilize:
AI tools
AI agents
Process automation approaches
to enhance efficiency and decision-making within medical safety operations.
5. Cross-functional Collaboration
Collaborate with:
Global development teams
Regulatory teams
Clinical teams
Safety stakeholders
to integrate safety insights into product development and lifecycle management.
Communicate safety findings clearly to diverse stakeholders.
Required Qualifications
Educational Qualification
One of the following:
Degree in:
Pharmacy
Nursing
Pharmacology
Life Sciences
OR Medical degree (required for medical review responsibilities)
Experience
Minimum 3 years of experience in drug development within the pharmaceutical industry
Preferred:
At least 2 years in patient safety roles
Operational or medical pharmacovigilance experience
Required Skills & Expertise
Pharmacovigilance & Clinical Safety
Strong knowledge of:
Clinical trial methodology
Drug safety principles
Regulatory requirements
Scientific methodology
Statistical concepts
Experience contributing to:
Safety reports
Regulatory documentation
Safety issue management
Safety Signal Management
Experience in:
Signal detection
Safety evaluation
Causality assessment
Risk management
Ability to interpret complex clinical safety data accurately.
Communication & Collaboration
Strong verbal and written communication skills.
Ability to:
Present safety information clearly
Collaborate across global teams
Communicate with diverse stakeholders
Fluency in spoken and written English.
AI & Digital Innovation
Preferred experience using:
Professional AI tools
AI agents
Automation technologies
for process improvement in pharmacovigilance and medical safety.
Preferred Skills
Experience managing:
Clinical safety issues
Regulatory safety escalations
Compliance-related safety activities
Scientific publication authorship experience is advantageous.
Working at Novartis
Novartis is a global healthcare company focused on reimagining medicine to improve and extend people’s lives through scientific innovation, collaboration, and patient-centered healthcare solutions.
Employees benefit from:
Global career opportunities
Innovative healthcare projects
Collaborative scientific culture
Learning and professional development support
Inclusive workplace practices
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