Senior Medical Safety Lead | Novartis
Company: Novartis Careers
Position: Senior Medical Safety Lead
Job ID: REQ-10076935
Location: Hyderabad
Division: Development
Business Unit: Development
Functional Area: Research & Development
Employment Type: Regular | Full-Time
Posted On: April 30, 2026
Role Overview
The Senior Medical Safety Lead is responsible for leading and overseeing the drug safety and pharmacovigilance (PV) activities across clinical development and post-marketing stages.
This role ensures:
Patient safety monitoring
Adverse event evaluation
Safety signal detection
Risk management throughout the product lifecycle
Regulatory compliance for drug safety
It provides strategic and operational safety input across:
Clinical trials
Post-marketing surveillance
Regulatory submissions
Global development programs
Key Responsibilities
1. Drug Safety & Surveillance Leadership
Lead safety surveillance activities including:
Monitoring adverse event reports
Conducting medical review of safety cases
Assessing causality and relatedness to product
Ensuring follow-up of safety reports
Oversee:
Clinical trial safety monitoring
Post-marketing safety programs
Risk assessment processes
2. Signal Detection & Risk Management
Responsible for:
Safety signal detection using structured tools
Evaluation of aggregate safety data
Trend analysis across clinical and real-world data
Identification of emerging safety risks
Support:
Risk mitigation strategies
Lifecycle safety evaluation
3. Individual Case Safety Assessment (ICSR)
Perform or oversee:
Medical evaluation of individual case reports
Literature review of adverse events
Line listing reviews
Medical assessment of quality defects
Preparation of investigator notifications
Ethics committee reporting
4. Regulatory & Medical Authority Interactions
Provide input for:
Regulatory authority responses
Health authority safety queries
Legal safety-related inquiries
Country organization safety requests
Support preparation of:
Safety data for regulatory review boards
Clinical safety documentation
5. Clinical Development Support
Contribute to:
Clinical study protocols
Clinical study reports (CSRs)
Investigator brochures
Regulatory submission documents
Clinical safety summaries
Clinical overviews
6. Risk Management Planning
Lead or contribute to:
Safety Profiling Plans (SPP)
Risk Management Plans (RMP)
Safety updates and lifecycle tracking
Effectiveness monitoring of safety actions
7. Cross-Functional Collaboration
Work closely with:
Clinical Development teams
Regulatory Affairs
Medical Affairs
Medical Information
Epidemiology
Statistics
Safety Data Management
Support integrated safety decision-making across functions.
8. Safety Operations Guidance
Provide guidance on:
Adverse event coding
Causality assessment
Expectedness evaluation
Medical safety case processing
Required Qualifications
Education
One of the following:
Medical Degree (MBBS or MD) — preferred/essential for medical review responsibilities
PharmD
PhD (relevant field)
Bachelor of Science in Pharmacy
Bachelor of Science in Nursing
Experience
Candidates should have:
6+ years in drug development (pharma industry)
AND
At least 4 years in patient safety / pharmacovigilance roles
Functional Expertise
Strong experience in:
Drug development lifecycle
Clinical trial methodology
Regulatory requirements
Scientific and medical writing
Statistical interpretation of safety data
Technical & Analytical Skills
Ability to:
Analyze and interpret safety data
Conduct medical assessments of adverse events
Identify safety signals
Prepare safety evaluations and reports
Communicate findings clearly in writing and presentations
Soft Skills
Strong capabilities in:
Cross-functional collaboration
Scientific communication
Decision-making under uncertainty
Attention to detail
Critical thinking
Stakeholder management
Regulatory interaction
Language Requirement
Fluent English (written and spoken)
What Novartis Looks For
Ideal candidates demonstrate:
Strong pharmacovigilance and drug safety expertise
Experience in clinical and post-marketing safety systems
Ability to interpret complex safety datasets
Strong regulatory and scientific judgment
Leadership in cross-functional environments
Commitment to patient safety and compliance
Why Join Novartis?
This role offers the opportunity to:
Lead global drug safety programs
Directly impact patient safety worldwide
Work across clinical and commercial product lifecycles
Collaborate with global regulatory and scientific teams
Shape risk management strategies for innovative medicines
Helpful Links
Careers
People & Culture
Benefits & Rewards
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