Medical Safety Lead
REQ-10059244
Hyderabad, India
Site: Hyderabad (Office)
Division: Development
Business Unit: Innovative Medicines
Company / Legal Entity: IN10 (Novartis Healthcare Private Limited)
Functional Area: Research & Development
Job Type: Full-time | Regular
Shift Work: No
Date Posted: August 21, 2025
As part of the Medical Safety organization, the Medical Safety Lead (MSL) supports the Global Program Safety Lead (GPSL) in ensuring robust patient safety oversight across the product lifecycle. The MSL plays a pivotal role in evaluating internal and external safety data, supporting regulatory submissions, managing safety signals, and ensuring compliance with pharmacovigilance (PV) regulations — all with the goal of improving patient outcomes and contributing to Novartis’ global success.
Monitor clinical safety of assigned projects/products through:
Literature reviews
Individual case evaluations
Signal detection activities
Conduct medical assessments of single case reports, including:
Follow-ups
Product quality defect evaluations
Investigator notifications
Ethics committee reports
Detect and evaluate safety signals using:
Spontaneous and solicited reports
Aggregate data analysis
Signal detection tools
Contribute to:
Regulatory authority queries and safety data submissions
Legal case responses
Country organization safety requests
Prepare safety input for Health Authority review boards
Assist GPSL and Sr. MSL with:
Core Data Sheet (CDS) updates
Clinical safety sections of submission documents (e.g., clinical overview)
Prepare safety input for:
Aggregate clinical safety reports
Safety Profiling Plans (SPP)
Risk Management Plans (RMP)
Work with teams across:
Clinical Development
Regulatory Affairs
Medical Affairs
Epidemiology
Medical Information
Biostatistics
PV Operations
Provide safety input for:
Study protocols and reports
Investigator brochures
Global Program/Brand Teams (GPT/GBT)
Clinical and licensing teams
Guide safety operations on:
AE causality/expectedness coding
Clinical evaluation of safety events
Risk/benefit profile interpretation
Required:
PharmD, M Pharm, or Medical Degree (MBBS or MD)
Preferred:
Specialization in a medical field
Medical degree is mandatory for those performing medical review of case reports
8+ years in pharmaceutical R&D or safety operations, including:
Patient safety
Drug development lifecycle
Clinical or postdoctoral medical experience
Proven experience in:
Clinical trial methodology
Regulatory compliance and documentation
Medical literature and safety signal analysis
Preparation of regulatory safety reports
Clinical Trials
Literature Review
Medical Safety & Pharmacovigilance
Medical Information & Records
Risk Management & Safety Science
Functional Team Collaboration
Regulatory Compliance
Medical Strategy
Signal Detection & Case Management
English (required – written and spoken)
At Novartis, we believe medical breakthroughs happen through the collaboration of smart, passionate people who care. Together, we:
Improve patient lives through science and compassion
Foster an inclusive culture built on courage, curiosity, and collaboration
Empower innovation in data, digital, and patient safety
🔗 Explore Our People & Culture
Novartis is committed to building:
An inclusive workplace
A diverse workforce representative of the communities we serve
A culture that drives bold innovation through collaboration
📩 Accessibility & Accommodation Requests:
Email: diversityandincl.india@novartis.com
(Include Job ID in your message)
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