Medical Safety Lead

Novartis

8+ years years

Not Disclosed

Hyderabad

10 Aug. 30, 2025

Job Description

Job Type: Full Time Education: PharmD, M Pharm, or Medical Degree (MBBS or MD) Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title:

Medical Safety Lead

Job ID:

REQ-10059244

Location:

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

About the Role:

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.

Key Responsibilities:

🔍 Safety Monitoring & Case Assessment

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

⚠️ Signal Detection & Evaluation

Detect and evaluate safety signals using:
- Spontaneous and solicited reports
- Aggregate data analysis
- Signal detection tools

🏛 Regulatory & Legal Support

Contribute to:
- Regulatory authority queries and safety data submissions
- Legal case responses
- Country organization safety requests
Prepare safety input for Health Authority review boards

📄 Safety Documentation & Submissions

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)

🤝 Cross-Functional Collaboration

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

🧠 Risk Assessment & Mitigation

Guide safety operations on:
- AE causality/expectedness coding
- Clinical evaluation of safety events
- Risk/benefit profile interpretation

Role Requirements:

🎓 Education:

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

💼 Experience:

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

Key Skills:

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

Languages:

English (required – written and spoken)

Why Join Novartis?

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

Diversity & Inclusion:

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)

Explore More:

🔗 Join the Novartis Talent Community
🔗 Benefits & Rewards

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