Pharmacovigilance Compliance Principal Specialist

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 scale? Do you thrive at the intersection of quality, regulatory expertise and strategic stakeholder engagement? Join 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 will include:

• 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 R&D 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.

 

Working at Novo Nordisk
Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations.

 

What we offer
There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.

Deadline
21 June 2026

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

 

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Experience Level

Senior Level