Global PV Process Excellence & Governance Lead

Freelio; Denmark; On-site; DKK 847,000 - 1,245,100; Full time

Job summary

Novo Nordisk is seeking a Principal Specialist, Pharmacovigilance Process Excellence to drive governance, continuous improvement, and inspection readiness within Global Patient Safety from Denmark/EU. You will work with the Director and EU QPPV Office to translate regulatory intelligence and process changes into actionable requirements, shaping PV governance and training.

Join a central GPS function that partners with global stakeholders to ensure compliant, efficient processes across the

Qualifications

• Bachelor's degree in life sciences and/or pharmaceutical industry with 5–10 years of pharmacovigilance experience.
• Significant PV operations, quality systems, governance or QPPV Office experience.
• Preferred: PV regulatory intelligence, process governance and training.
• Strong understanding of worldwide PV regulation and translating requirements into actionable execution.
• Fluent in English, written and spoken.

Responsibilities

• Facilitate regulatory intelligence governance board and act as deputy chair when required.
• Ensure operational rigor of the global governance framework for pharmacovigilance regulatory intelligence.
• Drive surveillance and assessment of emerging pharmacovigilance regulations, guidelines, and best practices.
• Translate regulatory changes into actionable organisational requirements.
• Maintain oversight of global and local regulatory changes impacting the PV system.
• Facilitate Process Governance board and change management framework.
• Drive maturity and inspection readiness of PV processes, standards, procedures and ways of working.
• Collaborate with stakeholders to harmonise global procedures and standards.

Skills

PV operations

Governance

Regulatory intelligence

Stakeholder management

English fluency

Education

Bachelor's degree in life sciences/pharmaceuticals

Job description

Novo Nordisk is seeking a Principal Specialist, Pharmacovigilance Process Excellence to drive governance, continuous improvement, and inspection readiness within Global Patient Safety from Denmark/EU. You will work with the Director and EU QPPV Office to translate regulatory intelligence and process changes into actionable requirements, shaping PV governance and training.

Join a central GPS function that partners with global stakeholders to ensure compliant, efficient processes across the