Are you looking for Novartis Risk Surveillance Lead Jobs in Hyderabad? Novartis is hiring experienced clinical research professionals to join its Risk-Based Quality Management (RBQM) team as a Risk Surveillance Lead. This hybrid opportunity is ideal for candidates with experience in clinical trials, RBQM, GCP, risk management, quality surveillance, and cross-functional clinical operations.

If you have a strong background in clinical research, pharmaceutical quality management, or CRO operations, this role offers an excellent opportunity to work with one of the world’s leading pharmaceutical companies while contributing to the quality and compliance of global clinical trials.

Job Details

About the Role

The Risk Surveillance Lead is responsible for driving the implementation and continuous improvement of Risk-Based Quality Management (RBQM) across assigned clinical studies. The successful candidate will oversee clinical quality risk surveillance, facilitate protocol risk assessments, monitor quality indicators, and collaborate with global cross-functional teams to ensure compliance with international regulatory requirements.

This position plays a critical role in improving clinical trial quality by leveraging analytics, risk monitoring, and quality governance throughout the drug development lifecycle.

Key Responsibilities

As a Risk Surveillance Lead at Novartis, you will:

• Lead protocol risk assessments across clinical, operational, regulatory, vendor, and data management functions.
• Define Critical-to-Quality (CtQ) factors and establish Quality Tolerance Limits (QTLs).
• Develop and maintain Integrated Quality Risk Management Plans (IQRMP).
• Collaborate with RBQM system teams to configure dashboards, analytics, and risk indicators.
• Perform centralized risk surveillance using RBQM analytical tools.
• Identify emerging clinical quality risks and recommend mitigation strategies.
• Facilitate cross-functional risk review meetings with study teams.
• Support sponsor audits, regulatory inspections, and quality assessments.
• Drive CAPA implementation and root cause analysis.
• Promote RBQM best practices, process improvements, and organizational learning.
• Act as a subject matter expert for Risk-Based Quality Management across global clinical programs.

Required Qualifications

Candidates should possess:

• Bachelor’s Degree in Pharmacy, Life Sciences, Health Sciences, Nursing, Biotechnology, or related discipline.
• Minimum 4 years of pharmaceutical or CRO industry experience.
• At least 1 year of Risk-Based Quality Management (RBQM) experience (preferred).
• Strong understanding of clinical trial execution and drug development.
• Working knowledge of:
  • ICH E6 Good Clinical Practice (GCP)
  • ICH E8 Guidelines
  • 21 CFR Part 11
• Experience in:
  • Risk Management
  • CAPA
  • Root Cause Analysis
  • Sponsor Audits
  • Regulatory Inspections
• Knowledge of RBQM platforms and clinical analytics systems.
• Strong analytical, communication, and stakeholder management skills.

Preferred Skills

• Clinical Trial Risk Surveillance
• Risk-Based Quality Management (RBQM)
• Clinical Operations
• Data Analytics
• Quality Management Systems
• GCP Compliance
• Regulatory Affairs
• Cross-functional Leadership
• Clinical Trial Governance
• Continuous Process Improvement

Why Join Novartis?

Joining Novartis means becoming part of one of the world’s leading healthcare innovators.

Benefits include:

• Hybrid working model
• Global clinical development exposure
• Career growth opportunities
• International project collaboration
• Continuous learning and development
• Inclusive and diverse workplace
• Competitive compensation package
• Opportunity to influence clinical trial quality worldwide

How to Apply

Application Link