Pharmacovigilance Vendor Governance Principal Specialist

Job description

### Job Summary Pharmacovigilance Vendor Governance Principal Specialist Team: PV Quality Compliance Monitoring, Global Patient Safety Location: Bangalore, Novo Nordisk Global Business Services (GBS), India Are you ready to shape how Novo Nordisk safeguards patient safety through world-class vendor governance? Do you thrive at the intersection of pharmacovigilance, compliance, and strategic partnerships? Join us and help build a governance framework that protects millions of patients worldwide. ### Your new role As our new External PV Vendor Governance Principal Specialist, you will own and operationalise the global PV system external vendor governance framework ensuring our vendors deliver to the highest quality, compliance and performance standards. You will work across a complex global landscape, turning strategy into action and driving continuous improvement in how we collaborate with external partners. ### Responsibilities - Designing, implementing and maintaining a robust governance framework for GPS over-sight of PV vendors, including risk-based oversight, criticality management and KPI monitoring - Oversee the performance and health of PV vendors within assigned segment to ensure delivery according to plan - time, budget, and quality. - Acting as the primary point of contact for relationship-level vendor issues and escalations, and leading the integration of new vendors into GPS strategy and operating models - Facilitating governance meetings, preparing decision material for leadership and compliance bodies, and overseeing vendor onboarding, transition, offboarding and major system/process changes - Performing routine PV vendor compliance assessments, KPI reviews, trend analyses and audits, and ensuring corrective and preventative actions are implemented effectively - Detecting early signals from GPS, affiliates and industry benchmarks, and driving improvements that fine-tune operational processes and safeguard regulatory compliance - Driving cross-functional initiatives that harmonise PV vendor compliance processes with GPS standards across regions, minimising duplication and maximising synergy - Ensuring inspection and audit readiness within your area of responsibility, and actively participating in PV inspections and audits ### Your Department In Research Development, you'll be part of a unit that explores bold scientific ideas and advances them into clinical testing. We combine curiosity, AI tools, and human data to develop transformative therapies. Through collaboration and operational excellence, we shape and deliver an innovative pipeline to meet future patient needs. You will join PV Quality Compliance Monitoring team within Global Patient Safety (GPS) the team responsible for ensuring the integrity, quality and compliance of our global pharmacovigilance system. We work closely with GPS departments, NN affiliates, RD, health authorities and contractual partners across Denmark, our Global Business Services centre in Bangalore, and beyond. Here, you will play a pivotal role in shaping how we govern external vendors and protect patient safety at scale. ### Your skills qualifications We are looking for an experienced PV professional who combines deep regulatory knowledge with a structured, proactive and collaborative mindset. To succeed in this role, you bring with you: - A Bachelor's degree, preferably in Life Sciences or Business Administration, and a minimum of 8 years' relevant pharmacovigilance experience within operations and/or vendor management - Expert knowledge of pharmacovigilance principles, international drug safety regulations and GxP, with prior experience working with CROs and external vendors - Solid understanding of PV and quality KPIs, GPS systems and databases, and the broader pharmaceutical industry, ideally with experience supporting regulatory authority inspections - Strong interpersonal, communication and stakeholder management skills, with the ability to align diverse perspectives across cultures, functions and geographies - A structured, detail-oriented approach combined with the ability to handle complex tasks with few defined procedures, work independently against deadlines, and drive innovation in compliance-critical environments - Fluency in English, both written and spoken #### Experience Level Senior Level Disclaimer : This job posting & Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.