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Medical Safety Lead

8+ years years
Not Disclosed
10 Aug. 29, 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)


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