Principal Specialist, PV Proc Excellence

Novo Nordisk

. Drive strategic governance and continuous improvement across Process Excellence areas .

Posted 9/23/2026full-timeBangalore • IndiaLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in pharmacovigilance operations, regulatory compliance, and process governance, with a strong ability to translate regulatory requirements into actionable strategies. Proven experience in managing complex assignments and fostering collaboration across diverse stakeholders.

Highest-signal resume keywords

Pharmacovigilance OperationsRegulatory ComplianceProcess GovernanceStakeholder ManagementStrategic Planning

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Pharmacovigilance ExperienceQuality SystemsRegulatory IntelligenceGovernance FrameworksCompliance MonitoringTraining DevelopmentOperational EfficiencyDocumentation ManagementEmerging Regulations SurveillanceInspection Readiness

Soft Skills

Strong CommunicationTeam-Oriented MindsetChange ReadinessFlexibilityDrive to Simplify

Industry Keywords

Life SciencesPharmacovigilance RegulationsGlobal Patient SafetyQPPV Office FunctionsOperational RigourFunctional StakeholdersTraining Governance FrameworkRole-Based LearningComplianceBest Practices

About the role

Key responsibilities & impact

Drive strategic governance and continuous improvement across Process Excellence areas
Facilitate regulatory intelligence and process governance boards, deputising for the Chair when required
Ensure governance frameworks operate with operational rigour and efficiency
Conduct surveillance and assessment of emerging pharmacovigilance regulations, guidelines and best practices
Translate regulatory developments into actionable organisational requirements
Maintain oversight of global and local regulatory changes impacting the pharmacovigilance system
Manage the impact of process changes across the pharmacovigilance system
Advance the maturity and inspection readiness of pharmacovigilance processes, standards and procedures
Harmonise global procedures with functional stakeholders
Support the global training governance framework, including GPS training curricula, role-based learning, effectiveness measurement and compliance monitoring
Own specific procedural documentation for the PV Process Excellence team
Collaborate with the Director, PV Process Excellence, EU QPPV, Deputy QPPVs, Global Patient Safety leadership, GPS departments, affiliates, R&D, health authorities and contractual partners

Requirements

What you’ll need

Bachelor's degree in life sciences or a related field
5–10 years' relevant pharmacovigilance experience
Significant experience within pharmacovigilance operations, quality systems, governance, compliance or QPPV Office functions
Strong understanding of worldwide pharmacovigilance regulation
Ability to translate regulatory requirements into pragmatic, high-quality execution
Experience in pharmacovigilance regulatory intelligence, process governance and training is an added advantage
Ability to provide strategic planning, governance and oversight across multiple large-scale, complex assignments
Strong communication and stakeholder-management skills
Team-oriented mindset with flexibility, change readiness and a drive to simplify while maintaining compliance
Fluency in English, both written and spoken

Benefits

Comp & perks

Inclusive recruitment process and equality of opportunity for all job applicants
Cross-functional collaboration and opportunities to build new skills
Support to perform at your best
Opportunity to grow alongside experienced colleagues
Trusted ownership and opportunity to speak up