Risk Surveillance Lead

HYDERABAD (IN)HYBRIDPOSTED: 8/8/2026
PHARMAFull-time
HIRING ORGANIZATIONNOVARTISPharmaceuticals / Healthcare
Novartis

ROLE DEFINITION & RESPONSIBILITIES

Drive adoption and implementation of Risk-Based Quality Management (RBQM) practices at trial and program levels.
Facilitate trial protocol risk assessments on critical-to-quality (CtQ) data and processes, establishing quality tolerance limits (QTLs) and mitigation plans.
Draft, maintain, and archive Integrated Quality Risk Management Plans (IQRMP) and collaborate with system teams to configure risk analytics.
Perform periodic central surveillance of aggregate clinical data to identify emerging risks, trends, and quality issues.
Lead cross-functional risk review meetings, support audit/inspection readiness, and share continuous improvement best practices.

REQUIRED VERIFIED SKILLS

Risk Management
Clinical Trials
GCP
Risk-Based Quality Management
ICH E6
ICH E8
Data Analysis

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting

ORGANIZATION CONTEXT & CULTURE

Novartis AG is a Swiss multinational pharmaceutical corporation, one of the largest in the world. It focuses on discovering, developing, manufacturing, and marketing innovative medicines to address significant health needs. The company's portfolio spans various therapeutic areas including oncology, immunology, neuroscience, and cardiovascular diseases.

TEAM SIZE: 76,000+ employees
INDUSTRY: Pharmaceuticals / Healthcare

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