PV Compliance Specialist, QPPV Office

<p><b>Team: QPPV Office &amp; PV Excellence, Global Patient Safety </b><br /><br /><b>Location: Bangalore, Novo Nordisk Global Business Services (GBS), India </b> </p><p>Are you passionate about pharmacovigilance and patient safety? Do you thrive at the intersection of compliance, quality and global collaboration? Join us in shaping how Novo Nordisk safeguards millions of patients through best-in-class PV processes – and help us stay ahead of an evolving regulatory landscape. </p><p><b>Your new role </b><br />As our new PV Compliance Specialist, you will play a key role in supporting QPPV Office coordination and the overall quality system across Headquarters and selected affiliates, as well as PV inspections, audits. You will work closely with the QPPV Office and PV Excellence Leadership Team, contributing to a strong compliance oversight framework that protects patients and reinforces Novo Nordisk's reputation as a trusted leader in drug safety. </p><p>Your day-to-day responsibilities will include: </p><li>Coordinating QPPV Office activities, including scheduling and facilitating QPPV Oversight meetings, collating metrics and data, and contributing to preparation and maintenance of global and local Pharmacovigilance System Master Files (PSMFs) </li><li>Driving PV Quality Management System excellence through development and implementation of KPIs, SOPs and QMS activities, and contributing to the Risk and Compliance committee with relevant Quality KPIs and risk reporting </li><li>Supporting oversight and management of deviations and CAPAs, ensuring structured follow-up and resolution, and acting as Deviation Owner and Change Request Owner when needed </li><li>Performing trending and analysis of PV-related findings, providing input to the PSMF, and communicating conclusions to relevant Process Owners </li><li>Supporting the "Inspection Responsible" role for HQ PV audits and inspections – including preparation, on-site/online support, training of stakeholders, rehearsals, pre-inspection requests and inspection room setup, as well as coordination of response preparation, CAPA monitoring and report distribution </li><li>Acting as a subject matter expert for stakeholders on PV audits and inspections, delivering relevant PV training in HQ and affiliates, and representing Novo Nordisk in internal working groups and at external conferences </li><li>Staying ahead of regulatory developments and industry best practices, and contributing to the continuous improvement of GPS processes, procedures and digital tools </li><p><b>Your new department </b><br />In Research &amp; 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.<br />You will join the QPPV Office &amp; PV Excellence team within Global Patient Safety (GPS), a global function dedicated to ensuring the highest standards of pharmacovigilance compliance across Novo Nordisk. Working closely with colleagues in Denmark, GPS Bangalore, GPS US and affiliates worldwide, the team plays a critical role in protecting patients and supporting our QPPV in fulfilling regulatory obligations. Your contribution will directly strengthen our inspection readiness, quality oversight and ability to navigate an increasingly complex regulatory environment. </p><p>Your skills &amp; qualifications </p><p>We're looking for a structured, analytical and self-driven professional who thrives in a global, cross-functional environment and is motivated by ensuring compliance that ultimately protects patients. You'll bring with you: </p><li>A Master's degree in life sciences and 5+ years of relevant experience within pharmacovigilance, including hands-on experience from various PV positions and with PV audits and inspections </li><li>Solid knowledge of PV principles, international drug safety regulatory requirements, GCP and GxP documentation, as well as a good understanding of PV and quality KPIs </li><li>Strong project coordination skills, experience working in international teams, and confidence as a user of relevant IT systems within the pharmaceutical industry </li><li>A structured approach with strong analytical skills, attention to detail and the ability to handle complex tasks with few defined procedures, work against deadlines and manage multiple priorities </li><li>Excellent interpersonal and communication skills, a team-oriented mindset with flexibility and change readiness, and a positive attitude that encourages knowledge sharing across cultural and professional boundaries </li><li>Fluency in English, both written and spoken </li>