Principal Specialist PV Proc. Excellence

Principal Specialist PV Proc. Excellence

Category: Reg Affairs & Safety Pharmacovigilance **Location:**Søborg, Capital Region of Denmark, DK Process Excellence, QPPV Office & PV Excellence, Global Patient Safety

Location: Denmark / EU

In this important role, you will work closely with the Director, Pharmacovigilance Process Excellence, the QPPV Office and the broader Global Patient Safety organization to ensure our pharmacovigilance system remains inspection-ready. Help shape how Novo Nordisk governs pharmacovigilance regulatory intelligence change, process change and training

Your new role

Are you passionate about shaping the future of pharmacovigilance excellence and ensuring that patient safety systems remain compliant, effective, innovative and inspection-ready?

As Principal Specialist,Pharmacovigilance Process Excellence, you will be responsible to drive strategic governance and continuous improvement of global pharmacovigilance processes and ways-of working. Working closely with the Director, PV Process Excellence, EU QPPV, Deputy QPPVs, Global Patient Safety leadership and cross-functional stakeholders, you will ensure operationalisation of strong governance of pharmacovigilance regulatory intelligence, process change and organisational training.

The PV Process Excellence team sits at the centre of the pharmacovigilance quality management system and is responsible for ensuring that emerging regulatory requirements are translated into sustainable, compliant, and efficient processes across the organisation.

Day-to-day, Your Responsibilities Will Include Assignment into one or more of the following Process Excellence areas;

Pharmacovigilance Regulatory Intelligence Governance

• Facilitation of the overall regulatory intelligence governance board, including acting a deputy of the Chair when required.
• Ensure operational rigor and efficiency of the global governance framework for pharmacovigilance regulatory intelligence.
• Drive systematic surveillance and assessment of emerging pharmacovigilance regulations, guidelines, and industry best practices,
• Ensure timely support and assessment of regulatory changes, and translation into actionable organisational requirements.
• Maintain oversight of global and local regulatory changes impacting the pharmacovigilance system.

Process Governance and Change Management

• Facilitation of the overall Process Governance board, including acting a deputy of the Chair when required.
• Ensure operational rigor and efficiency of the Process Governance and change management framework.
• Drive the maturity and inspection readiness of pharmacovigilance processes, standards, procedures, and ways of working.
• Ensure effective impact assessment and management of process changes across the pharmacovigilance system.
• Cooperate with functional stakeholders and procedural content owners to ensure harmonisation and alignment of global procedures and standards.

Training Governance and Capability Development

• Support the Director, PV Process Excellence to implement and oversee the global pharmacovigilance training governance framework.
• Operational support to functional stakeholders to ensure delivery of appropriate training strategies and learning interventions.
• Senior expertise to drive GPS training curricula, role-based learning requirements, training effectiveness measurement, and compliance monitoring.
• Ensure inspection readiness related to training records, competency management, and qualification requirements.

Other

• Primary ownership of specific procedural documentation of the PV Process Excellence team.

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, you will join the QPPV Office 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, our Global Business Services centre in Bangalore, NN affiliates, R&D, health authorities and contractual partners across the globe.

Your Skills & Qualifications

• We are looking for a structured, detail-oriented professional who thrives in a complex, global environment and is motivated by continuous improvement. To succeed in this role, you bring:
• A Batchelors degree in life sciences and/or pharmaceutical industry combined with a minimum of 5-10 years' relevant pharmacovigilance experience in Pharmacovigilance.
• Significant experience within pharmacovigilance operations, quality systems, governance, compliance, or QPPV Office functions
• Preferred; experience in PV regulatory intelligence, process governance and training
• Strong understanding of worldwide PV regulation and the ability to translate requirements into pragmatic, high-quality execution.
• Strong communication and stakeholder-management skills.
• Demonstrated ability to provide strategic planning, governance, and oversight across multiple large-scale, complex assignments.
• A team-oriented mindset with flexibility, change readiness, and a drive to simplify while maintaining compliance
• Fluency in English, both written and spoken

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.

Salary: For this role, the Annual Base Salary ranges from 847,000 to 1,245,100 DKK (DK), corresponding to the level of the position. The placement within the salary range will be assessed during the recruitment process based on the candidate’s skills, competencies, knowledge, and relevant experience.

Incentives and Benefits: The salary package may include short-term and/or long-term incentives as well as other employee benefits based on position level, location, functional area and relevant market benchmarks.

Learn more about our Reward Philosophy here.

Deadline

14th August

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.