Medical Safety Lead – Global Health
Job ID: REQ-10077883
Date: May 22, 2026
Location: Hyderabad, India
Work Model: Hybrid (12 days/month in office)
Company: Novartis Healthcare Private Limited
Division: Development (Global Health / Patient Safety)
Job Overview
The Medical Safety Lead is responsible for evaluating and monitoring clinical safety data across the product lifecycle. The role focuses on signal detection, medical assessment of adverse events, and ensuring regulatory compliance in pharmacovigilance activities.
This position plays a key role in protecting patient safety by collaborating with global cross-functional teams and supporting regulatory decision-making for Novartis therapies.
Key Responsibilities
A. Clinical Safety Monitoring
Monitor safety data from:
Clinical trials
Literature sources
Individual case safety reports (ICSRs)
Conduct ongoing signal detection and evaluation activities
Identify, assess, and track emerging safety signals using both single-case and aggregate data
B. Medical Review & Case Assessment
Perform medical evaluation of individual adverse event cases
Ensure accurate causality assessment and clinical interpretation
Guide adverse event coding and safety data classification
Ensure consistency in medical safety review standards
C. Regulatory & Safety Reporting
Contribute to responses for regulatory authorities and healthcare professionals
Support preparation of core safety documents:
Clinical safety overviews
Aggregate safety reports
Regulatory submission documents
Provide medical input into safety reporting and labeling updates
D. Cross-functional Collaboration
Collaborate with global clinical development and safety teams
Integrate safety insights into clinical programs and development strategies
Manage cross-functional safety issues including:
Regulatory inquiries
Compliance escalations
Risk mitigation actions
E. Safety Science & Strategy
Support interpretation of clinical safety data using scientific and statistical principles
Contribute to pharmacovigilance strategy across product lifecycle
Participate in safety governance discussions and decision-making
F. AI & Digital Innovation
Apply AI-enabled tools to improve pharmacovigilance workflows
Leverage AI agents to enhance signal detection and safety data analysis
Support digital transformation initiatives in medical safety processes
Minimum Requirements
Degree in Pharmacy, Nursing, Pharmacology, Life Sciences, or Medicine
(Medical degree required for roles involving individual case medical review)
Minimum 3 years of experience in drug development within pharmaceutical industry
At least 2 years of experience in patient safety / pharmacovigilance (preferred)
Strong understanding of:
Clinical trial methodology
Regulatory requirements
Scientific and statistical principles
Experience in authorship of scientific or safety-related publications
Strong communication and analytical skills for interpreting safety data
Desirable Skills
Experience using AI tools or digital agents in safety or pharmacovigilance processes
Experience managing complex clinical safety issues
Exposure to regulatory inspections and safety governance frameworks
Core Competencies
Pharmacovigilance & drug safety expertise
Clinical data interpretation
Regulatory compliance and safety reporting
Risk assessment and signal detection
Cross-functional stakeholder management
Scientific communication and documentation
Work Environment
Global pharmacovigilance and clinical safety function
Highly regulated environment with strong compliance requirements
Cross-functional collaboration across clinical, regulatory, and safety teams
Focus on patient safety, innovation, and continuous improvement
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Baddi | Solan |Rajasthan :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
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Dibrugarh | Diburghar | Guwahati |West Bengal :
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Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Rangpo |India :
Remote, India | Siliguri |Illinois :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Swords |Republic of China :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Tallinn |Hà Nội :
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Riyadh | Jeddah | Khulais | King Abdullah Economic City | Najran | Rabigh |Kuala Lumpur :
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Kyiv |Lima Region :
Lima |France :
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Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
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