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Pharmacovigilance Metrics Governance Principal Specialist New I

Novo Nordisk
6+ years
22 LPA - 40 LPA
Bangalore, India
1 June 22, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: ICH guidelines, ICSR Case Processing, Labelling Assessment, MedDRA Coding, mRS and EQ-5D-5L, Triage of ICSRs, WHO DD Coding

Pharmacovigilance Metrics Governance Principal Specialist

Location: Bangalore, Karnataka, India
Company: Novo Nordisk Global Business Services (GBS)
Department: Global Patient Safety (PV Quality & Compliance Monitoring)
Employment Type: Full-Time

Role Summary

The Pharmacovigilance Metrics Governance Principal Specialist is responsible for supporting and strengthening the governance framework for pharmacovigilance quality, compliance, and performance monitoring across Novo Nordisk's global PV system. The role focuses on developing and maintaining robust metrics governance processes, driving continuous improvement initiatives, ensuring compliance with global pharmacovigilance regulations, and supporting inspection readiness.

This position works closely with Global Patient Safety (GPS), affiliates, external vendors, and cross-functional stakeholders to ensure effective oversight of PV quality and compliance metrics. The individual will play a key role in harmonizing PV governance processes, supporting strategic decision-making, and fostering a culture of quality, compliance, and operational excellence across the global PV organization.

Key Responsibilities

PV Metrics Governance & Compliance

  • Support implementation and maintenance of the global PV metrics governance framework.

  • Ensure adherence to pharmacovigilance quality and compliance objectives.

  • Monitor and evaluate PV system performance through quality and compliance metrics.

  • Support governance processes for centralized PV monitoring and reporting.

Metrics Reporting & Governance Meetings

  • Operationalize and facilitate internal metrics governance meetings.

  • Ensure effective reporting, monitoring, and escalation of PV quality and compliance issues.

  • Prepare metrics dashboards, governance reports, and performance summaries.

  • Support leadership decision-making through data-driven insights.

Quality & Continuous Improvement

  • Drive PV quality improvement initiatives across GPS and affiliate organizations.

  • Identify process gaps and implement corrective actions.

  • Harmonize PV quality processes with internal standards and global regulatory requirements.

  • Promote continuous improvement and operational excellence initiatives.

CAPA Management & Inspection Readiness

  • Facilitate Corrective and Preventive Actions (CAPA) in collaboration with stakeholders.

  • Track CAPA effectiveness and closure activities.

  • Support inspection and audit readiness activities.

  • Participate in regulatory inspections and audit preparation activities.

Stakeholder & Cross-Functional Collaboration

  • Build strategic partnerships with internal and external stakeholders.

  • Collaborate with affiliates, PV operations teams, quality groups, and external partners.

  • Benchmark PV governance practices against industry standards.

  • Support alignment and consistency across global PV processes.

PV Systems & Process Optimization

  • Support governance of PV databases, systems, and reporting tools.

  • Improve ways of working to reduce duplication and increase efficiency.

  • Contribute to process standardization and simplification initiatives.

  • Ensure consistency across GPS and affiliate activities.

Required Qualifications

Education

One of the Following:

  • Bachelor's Degree in Life Sciences

  • Bachelor's Degree in Pharmacy

  • Bachelor's Degree in Biotechnology

  • Bachelor's Degree in Biological Sciences

  • Related Healthcare or Scientific Degree

Experience

  • Minimum 6+ years of Pharmacovigilance experience.

  • Strong experience in PV Operations, Quality, Compliance, or Governance.

  • Experience working within global pharmacovigilance environments.

  • Exposure to regulatory inspections and audit activities.

Preferred Experience

  • Experience with PV metrics management and governance.

  • Experience supporting quality systems and compliance programs.

  • Experience managing CAPAs and inspection readiness.

  • Experience working with global affiliates and external vendors.