Risk Surveillance Lead

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

ROLE DEFINITION & RESPONSIBILITIES

Facilitate trial protocol risk assessments across cross-functional domains to define Critical-to-Quality data and Quality Tolerance Limits.
Draft, maintain, and archive Integrated Quality Risk Management Plans (IQRMP) for assigned clinical trials.
Collaborate with RBQM system teams to configure risk indicators, quality tolerance limits, and operational analytics.
Conduct periodic central data surveillance at study and program levels to identify emerging clinical quality risks.
Lead risk review meetings with trial teams to drive root cause identification, mitigation planning, and inspection readiness.

REQUIRED VERIFIED SKILLS

Risk Based Quality Management (RBQM)
GCP
ICH E6
ICH E8
Risk Assessment
Data Analysis
Root Cause 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

READY TO SUBMIT?

Verify your capability profile and matching credentials before submitting direct applications.