Medical Safety Lead

Sandoz

5+ years

Not Disclosed

Remote, India, Telangana, India

Openings: 10 June 9, 2026

Job Description

Job Type: Full Time Hybrid Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Apache Spark, Artificial Intelligence (AI), Big Data, Data Governance, Data Literacy, Data Management, Data Quality, Data Science, Data Strategies, Data Visualization, Machine Learning (ML), Master Da, Auditing, Audit Management, Audits Compliance, Communication, Continued Learning, Decision Making, Gmp Procedures, Inspection Readiness, Managing Ambiguity, Organizing, People Management and Leadershi, Bachelor’s Degree (BS) or Master’s Degree (MS) in: Life Sciences Pharmacy Biotechnology Biomedical Sciences Chemistry Regulatory Affairs Or related scientific disciplines, Budget Management, Clinical Trials, Negotiation Skills, Process Improvement, Project Planning, Vendor Management, Waterfall Model, Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Intern, Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Intern, Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Intern, Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Intern, Causality Assessment, Change Control, Continual Improvement Process, Data Analytics and Digital, GDP Knowledge, gmp knowledge, HSE Knowledge, Manufacturing Process, Manufacturing Production, Operational Excellence, Process, Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Collaboration, Data Integrity, Decision Making Skills, Lifesciences, Clinical Research, Clinical Trials, Curious Mindset, Databases, Drug Development, Job Description, Lifesciences, Medical Communication, Medical Information, Medical Writing, Military Intelligence, Pat, Clinical SAS Programming, Clinical Trials, Cross-Functional Teams, Drug Development, Lifesciences, Negotiation Skills, People Management, Problem Solving Skills, Regulatory Compliance, Risk Management, Strategy Execution, Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance, Clinical Trials, Functional Teams, Literature Review, Management Skills, Medical Information, Medical Records, Medical Strategy, Pharmacovigilance, Regulatory Compliance, Risk Management, Safety Scien, Coaching Skills, Data Science, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Pro, Collaboration, Communication Skills, gmp, GMP Guidelines, Operational Excellence, Problem Solving Skills, Quality Agreements, Quality Compliance, Quality Management, Quality Standards, Regulatory Requ, Communication Skills, Continual Improvement Process, Master Data, Material Requirements Planning (Mrp), Materials Management, People Management, Production Planning, Supplier Relationship Management (Srm), Supply-Chain Man, CPC Certified, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, 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, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Medical Safety Lead
Job ID: REQ-10028869
Location: India (Telangana)
Company: Sandoz
Division: Sandoz
Business Unit: Administration & Facility
Functional Area: Research & Development
Employment Type: Full-Time, Regular
Shift Work: No

Position Summary

The Medical Safety Lead is responsible for monitoring and evaluating the clinical safety profile of products and development programs. The role involves medical review of adverse events, signal detection, risk assessment, regulatory safety support, and collaboration with cross-functional teams to ensure patient safety and regulatory compliance.

Key Responsibilities

Clinical Safety Monitoring

Monitor the clinical safety of products and projects.
Conduct literature reviews and safety surveillance activities.
Evaluate individual adverse event cases and safety data.
Respond appropriately to safety-related medical inquiries.

Medical Review & Case Assessment

Perform medical review and assessment of adverse event cases.
Collect and evaluate follow-up information when required.
Assess product quality complaints associated with adverse events.
Review line listings and individual case safety reports (ICSRs).
Prepare investigator notifications and periodic medical assessments for ethics committees.

Signal Detection & Risk Evaluation

Identify potential safety signals from solicited and unsolicited reports.
Conduct signal detection, monitoring, validation, and evaluation activities.
Assess emerging risks and their impact on product safety profiles.

Regulatory Safety Support

Provide medical input for responses to regulatory authority inquiries.
Prepare and review safety data packages for Health Authority assessments and review boards.
Support regulatory submissions involving safety-related information.

Safety Communication & Stakeholder Support

Respond to safety-related queries from healthcare professionals and internal stakeholders.
Support country organizations on product safety matters.
Contribute to responses for legal and compliance-related safety questions.

Medical Expertise & Risk Assessment

Provide expert clinical evaluation of adverse event reports.
Assess medical conditions, causality, seriousness, and expectedness of events.
Evaluate potential implications of safety findings on product benefit-risk profiles.

Cross-Functional Collaboration

Work closely with teams across:
- Clinical Development
- Regulatory Affairs
- Medical Affairs
- Medical Information
- Biostatistics
- Safety Data Management
- Epidemiology
- Other relevant functions
Support integrated safety assessment and decision-making processes.

Departmental Contributions

Contribute to departmental goals, objectives, and continuous improvement initiatives.
Support safety governance activities and operational excellence programs.
Participate in marketing sample distribution activities where applicable.

Minimum Requirements

Education

Medical, Scientific, Pharmacy, Life Sciences, or related healthcare degree.

Experience

Minimum 8+ years of experience in:
- Pharmacovigilance (PV)
- Drug Safety
- Medical Review of Safety Cases
- Clinical Safety Assessment

Required Expertise

Technical Competencies

Pharmacovigilance
Drug Safety Surveillance
Medical Review of ICSRs
Signal Detection & Management
Risk Assessment
Safety Data Analysis
Regulatory Safety Reporting
Benefit-Risk Evaluation
Literature Surveillance
Safety Governance

Leadership Competencies

Cross-functional Collaboration
Scientific Judgment
Decision-Making
Stakeholder Management
Problem Solving
Communication & Influence

About Sandoz

Sandoz is a global leader in generic and biosimilar medicines, providing over 900 million patient treatments annually across more than 100 countries. The company is committed to expanding access to affordable, high-quality medicines through innovation, strategic partnerships, and sustainable growth.

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Medical Safety Lead

Job Description

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