PV Compliance Principal Specialist, QPPV Off

Job description

### Job Summary PV Compliance Principal Specialist, QPPV Off **Team: QPPV Office PV Excellence, Global Patient Safety** **Location: Bangalore, Novo Nordisk Global Business Services (GBS), India** Are you ready to shape the future of pharmacovigilance compliance at a global scaleDo you thrive at the intersection of quality, regulatory expertise and strategic stakeholder engagementJoin us as our new PV Compliance Principal Specialist and play a pivotal role in safeguarding patient safety across Novo Nordisk's worldwide operations. ### Your new role As PV Compliance Principal Specialist, you will be the driving force behind our PV audit and inspection readiness, while supporting the QPPV Office in fostering a culture of excellence, collaboration and continuous improvement. You will influence the performance of our PV quality system across Global Patient Safety (GPS) and our affiliates, ensuring we consistently meet the highest standards of compliance. ### Your key responsibilities - Acting as "Inspection Responsible" for HQ PV audits and inspections, coordinating end-to-end activities including preparation, on-site/online support, response coordination and submissions to Competent Authorities - Coordinating audit/inspection follow-up activities, compiling draft responses, monitoring CAPAs until closure, and performing trending and analysis of PV-related findings - Supporting the QPPV Office in overseeing global pharmacovigilance activities, including the coordination, preparation and maintenance of global and local Pharmacovigilance System Master Files (PSMFs) - Facilitating QPPV Oversight meetings, ensuring relevant subject matter experts are engaged and metrics and data are presented effectively - Driving the development, implementation and continuous improvement of KPIs, SOPs and QMS activities, maintaining a strong compliance oversight framework - Securing effective deviation and CAPA management and ensuring digital tools and processes support central monitoring and reporting of global PV system quality - Acting as subject matter expert and advisor for stakeholders across HQ and affiliates, representing Novo Nordisk in internal and external working groups, conferences and training initiatives ### Your new 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. Within RD sits Global Patient Safety, where the QPPV Office PV Excellence team plays a critical role in ensuring the safety of our medicines for millions of patients worldwide. You will work closely with the QPPV, deputy QPPV, GPS Leadership Team and stakeholders across Denmark, Bangalore, the US and our global affiliate network partnering across disciplines including Quality, Global Development, Regulatory Affairs, Legal and Corporate Communications to drive compliance, inspection readiness and continuous improvement. ### Your skills qualifications We are looking for an experienced PV professional with strong compliance expertise, sharp analytical skills and the confidence to set direction in a complex global landscape. To succeed in this role, we expect you to bring: - A Master's degree (or PhD) in life sciences and 8+ years of relevant experience within pharmacovigilance or a closely related field - Extensive knowledge of PV principles, international drug safety regulatory requirements, GCP and GxP documentation, with substantial hands-on experience in PV audits and inspections - A firm understanding of PV and quality KPIs, combined with strong project leadership skills to set strategy, define activities and deliver in close collaboration with key stakeholders - Excellent analytical, planning and coordination skills, with a strong sense of structure, timeliness and attention to detail and the ability to handle complex tasks with few or no defined procedures - Strong interpersonal, communication and negotiation skills, with proven experience working in international and diverse professional teams - Fluency in English, both written and spoken - You bring professional authority to every interaction, a positive and flexible mindset, and a genuine drive to identify better practices and create improvements across the organisation. #### 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.