Safety Surveillance Process Lead: Audits & Inspections

Novo Nordisk A/S

Søborg

On-site

DKK 847,000 - 1,245,000

Full time

2 days ago
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Benefits offered by this job

Incentives and Benefits

Job summary

Novo Nordisk A/S in Søborg, Capital Region of Denmark, seeks a Safety Surveillance Principal Process Specialist to keep Safety Surveillance audit-ready and ensure monitoring processes stay compliant and valuable. You will lead inspections, drive regulatory surveillance, and help integrate processes after acquisitions.

You will bring a life sciences master’s degree and 5–7 years in pharmacovigilance, with hands-on inspection setup experience and strong stakeholder management across functions and

Qualifications

  • Master’s degree in Life Sciences or related field.
  • 5–7 years in pharmacovigilance, incl. clinical trials.
  • Hands-on experience enabling inspection set-ups.

Responsibilities

  • Lead audits and inspections: coordinate Safety Surveillance contributions, prepare colleagues for interviews, ensure high-quality responses and keep oversight of findings and corrective actions.
  • Act as Process Expert for signal management and co-drive Regulatory Surveillance, ensuring compliance with legislation.
  • Handle deviations and change requests in collaboration with Safety Surveillance and other functions.
  • Support integration and acquisition activities by integrating pharmacovigilance processes and systems.
  • Contribute to process improvement projects aligned with Safety Surveillance objectives.

Skills

Pharmacovigilance
Audits & inspections
Stakeholder management

Education

Master’s degree in Life Sciences

Job description

Novo Nordisk A/S in Søborg, Capital Region of Denmark, seeks a Safety Surveillance Principal Process Specialist to keep Safety Surveillance audit-ready and ensure monitoring processes stay compliant and valuable. You will lead inspections, drive regulatory surveillance, and help integrate processes after acquisitions.

You will bring a life sciences master’s degree and 5–7 years in pharmacovigilance, with hands-on inspection setup experience and strong stakeholder management across functions and

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