Safety Surveillance Principal Process Specialist

Novo; Søborg; On-site; DKK 847,000 - 1,245,000; Full time

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

Category: Reg Affairs & Safety Pharmacovigilance

Safety Surveillance Principal Process Specialist

Location: Søborg, Capital Region of Denmark, DK

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Your impact begins here

As Safety Surveillance Principal Process Specialist, you will keep Safety Surveillance ready for every audit and inspection, and make sure the way we monitor safety information keeps pace with legislation. You will be a highly visible process expert: leading our contribution to inspections, co-driving regulatory surveillance and shaping how we integrate processes after acquisitions. Your work keeps surveillance of Novo’s marketed and developmental products compliant, simpler and focused on the work that adds most value.

What you’ll bring

You know drug safety from the inside, and you know what it takes to get an organisation ready for an inspection. You will also bring:

• A Master’s degree in Life Sciences, such as Pharmacy, Medicine, Veterinary Science or Biology, or a related field.
• At least 5–7 years of experience in pharmacovigilance, including supporting safety activities in clinical trials.
• Hands‑on experience facilitating inspection set‑ups, training colleagues and preparing an organisation for audits and inspections.
• Expertise in Safety Surveillance processes and an enterprise mindset: you understand the end‑to‑end process and can turn complex internal and external requirements into practical ways of working.
• A solid background in handling deviations and implementing process changes.
• Excellent communication and stakeholder management skills, with the ability to engage and influence senior internal stakeholders and external parties, and a collaborative mindset across functions and geographies.
• Resilience and a calm demeanour in a very busy environment, with the ability to multitask and prioritise your workload through complexity and challenge.

Desirable, but not essential:

Experience in process management and project management.

What you’ll do

You will be a recognised expert in key Safety Surveillance processes, helping the team work with greater simplicity and focus. The role covers a diverse range of tasks, and you could be part of an inspection from day one.

• Lead audits and inspections: coordinate Safety Surveillance contributions, prepare colleagues for interviews, ensure high‑quality responses and keep oversight of findings and the associated corrective and preventive actions.
• Act as Process Expert for the signal management process and co-drive the Regulatory Surveillance process, ensuring full compliance with applicable legislation.
• Handle deviations and change requests in close collaboration with colleagues in Safety Surveillance and other relevant functions.
• Support integration and acquisition activities by helping integrate pharmacovigilance processes and systems following company or product acquisitions and mergers.
• Contribute to process improvement projects aligned with our strategic objectives, using your end‑to‑end view of Safety Surveillance.

Who you’ll work with

You will join the Safety Surveillance Centre of Expertise, a team of five engaged and skilled colleagues within Safety Surveillance, and report to the Director of Safety Surveillance Centre of Expertise.

Safety Surveillance is a department within Global Patient Safety in Research & Development, with departments in Bangalore, India, and Boston, US. Together, we are globally accountable for surveillance of all safety information for Novo’s marketed products and products in development. We also handle safety label updates, Risk Management Plans and aggregate reports.

You will work closely with colleagues across Safety Surveillance and partner with Global Patient Safety, other headquarters functions and affiliates during audits and inspections. When processes need to change, you will bring the right people together, create clarity on what needs to happen and help the team move forward with pace.

What you can expect here

You will have real visibility as a process expert, and the opportunity to influence how Safety Surveillance works and make a lasting impact. You will be trusted to take ownership, encouraged to make your voice heard, and supported by colleagues who give honest feedback and never compromise on patient safety or quality.

The pace is high and the work is varied. Through process improvement projects and a broad range of tasks, you will build new skills and deepen your understanding of safety surveillance end to end.

Salary: For this role, the Annual Base Salary ranges from 847,000 to 1,245,100 DKK, 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

We are an equal opportunities employer and are committed to an inclusive recruitment process and equality of opportunity for all applicants.