Pharmacovigilance Metrics Governance Principal Specialist

Job description

### Job Summary Pharmacovigilance Metrics Governance Principal Specialist Team: PV Quality Compliance Monitoring, Global Patient Safety Location: Bangalore, India Are you passionate about pharmacovigilance, quality and compliance? Do you want to help shape the governance framework that safeguards patient safety on a global scale? Join us in PV Excellence and play a key role in driving how we monitor, measure and continuously improve the performance of our global PV system. ### Your new role As PV Metrics Governance Principal Specialist, you will support the digital tools and processes that underpin our governance framework for central monitoring, measuring and reporting of global PV system quality and compliance metrics. You will work across Global Patient Safety (GPS), affiliates and external partners to ensure coherence, synergy and continuous improvement. ### Your key responsibilities - Supporting the implementation and maintenance of a robust governance framework for GPS oversight of the global PV system, ensuring adherence to quality and compliance objectives - Operationalising internal metrics governance meetings to ensure optimal reporting and escalation of issues relating to PV system quality and compliance - Driving improvement initiatives and cross-functional projects that harmonise PV quality and compliance processes with internal and external standards - Building strategic partnerships with internal and external stakeholders, benchmarking against industry standards, and anticipating needs through regular engagement and feedback loops - Performing and facilitating corrective and preventive actions in collaboration with stake-holders, and ensuring inspection and audit readiness within your area - Designing ways of working that create synergy across GPS and affiliate activities, mini-mise duplication, and foster a culture of quality and continuous improvement ### Your new department In Research Development, you'll be part of a unit that explores bold scientific ideas and ad-vances 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. Within RD, 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 ### Your skills qualifications We are looking for an experienced PV professional who thrives in a complex, global stakeholder landscape and who can balance independence with strong collaboration. To succeed in this role, you'll bring: - A Bachelor's degree, preferably in Life Sciences, with a minimum of 6 years' relevant pharmacovigilance experience in operations - Expert knowledge of pharmacovigilance principles and international regulatory requirements regarding drug safety, combined with a firm understanding of PV and quality KPIs and excellent knowledge of GxP - Solid knowledge of databases and systems utilised by GPS, and experience participating in regulatory authority inspections - Strong interpersonal, communication and stakeholder management skills, with the ability to reach agreement on matters of strategic importance across diverse professional and cultural backgrounds - A structured, detail-oriented and quality-focused mindset, with the ability to handle com-plex tasks where few or no defined procedures exist paired with innovation, flexibility and a drive for simplicity while maintaining compliance - 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.