Safety Surveillance Principal Specialist

Cari; Søborg; Remote; DKK 847.000 - 1.245.000; Vollzeit

Zusammenfassung

Novo Nordisk in Søborg, Denmark is seeking a Safety Surveillance Principal Specialist to lead the safety surveillance strategy for Health Authority responses across the incretin portfolio, mainly in diabetes and obesity treatments.

You will drive benefit–risk thinking, influence critical decisions, and represent Safety Surveillance in Health Authority meetings, ensuring safety messages are clear and timely.

Qualifikationen

• Master’s degree in Life Sciences (e.g. Pharmacy, Medicine, Veterinary Medicine or Biology).
• Extensive experience within drug safety, pharmacovigilance, drug development processes, global regulatory requirements, GxP standards and medical concepts.
• Demonstrated ability to identify challenges, shape strategies and translate them into clear, actionable steps.
• Strong stakeholder management and the ability to influence decisions through clear, concise communication.
• Solid experience with Health Authority negotiations, including meetings.
• The ability to communicate clearly, in writing and verbally, and to turn complexity into clear recommendations.
• A self-driven, ethical and adaptable approach: you work independently, address issues proactively and stay flexible when situations or priorities change.
• A team-player mindset: you show empathy, take care of colleagues, build effective connections and collaborate seamlessly with internal and external stakeholders.

Aufgaben

• Act as the safety surveillance lead for strategic, scientific responses to safety Q&A from all Health Authority interactions.
• Maintain overview of activities, including studies, submissions and questions and answers from Health Authorities.
• Represent Safety Surveillance in Health Authority meetings.
• Maintain overview of safety contributions to study reports, regulatory submissions, protocols and other key documents, and ensure relevant input to continued development activities.
• Contribute to benefit–risk communication and ensure clear, aligned and timely safety messaging for internal stakeholders and Health Authorities.
• Drive governance and decision-making across cross-functional areas and senior fora, and mentor colleagues by setting standards for scientific quality, decision-making and collaboration.

Kenntnisse

Stakeholder management

Clear communication

Strategic thinking

Independent working

Team collaboration

Health Authority negotiations

Ausbildung

Master’s degree in Life Sciences

Jobbeschreibung

Safety Surveillance Principal Specialist

Job title: Safety Surveillance Principal Specialist

Department: Safety Surveillance Post-Marketing Cardiometabolic III

Location: Søborg, Denmark

Your impact begins here

As Safety Surveillance Principal Specialist, you will lead the safety surveillance strategy for responses to Health Authority questions across Novo’s incretin portfolio, mainly within diabetes and obesity treatment. You will drive benefit–risk thinking, influence critical decisions and represent Safety Surveillance in Health Authority meetings. Your judgement helps ensure the safety of treatments for people living with serious chronic diseases is understood clearly and communicated on time.

What you’ll bring

You are an experienced, scientifically driven colleague who thrives on complex safety challenges and turns data into meaningful insight.

• A master’s degree in Life Sciences (e.g. Pharmacy, Medicine, Veterinary Medicine or Biology).
• Extensive experience within drug safety, pharmacovigilance, drug development processes, global regulatory requirements, GxP standards and medical concepts.
• Demonstrated ability to identify challenges, shape strategies and translate them into clear, actionable steps.
• Strong stakeholder management and the ability to influence decisions through clear, concise communication.
• Solid experience with Health Authority negotiations, including meetings.
• The ability to communicate clearly, in writing and verbally, and to turn complexity into clear recommendations.
• A self-driven, ethical and adaptable approach: you work independently, address issues proactively and stay flexible when situations or priorities change.
• A team-player mindset: you show empathy, take care of colleagues, build effective connections and collaborate seamlessly with internal and external stakeholders.

What you’ll do

You will lead high-impact activities across the incretin portfolio, help set the direction for safety surveillance, and act as a trusted safety leader for key stakeholders. Clear communication, sound judgement and taking ownership will be part of your everyday work.

• Act as the safety surveillance lead for strategic, scientific responses to safety Q&A from all Health Authority interactions.
• Maintain overview of activities, including studies, submissions and questions and answers from Health Authorities.
• Represent Safety Surveillance in Health Authority meetings.
• Maintain overview of safety contributions to study reports, regulatory submissions, protocols and other key documents, and ensure relevant input to continued development activities.
• Contribute to benefit–risk communication and ensure clear, aligned and timely safety messaging for internal stakeholders and Health Authorities.
• Drive governance and decision-making across cross-functional areas and senior fora, and mentor colleagues by setting standards for scientific quality, decision-making and collaboration.

Who you’ll work with

You will join the Post-Marketing Cardiometabolic III team in Safety Surveillance Post-Marketing, an area within Global Patient Safety based in Søborg, Denmark, with a department in Bangalore, India. The area has global responsibility for the portfolio of marketed products and consists of 7 teams across Denmark and India.

As a team, we are the bridge between clinical development and post-marketing. We handle clinical studies and submissions and lead strategic, scientific responses to safety Q&A from Health Authorities around the world on our GLP-1 portfolio.

You will work both independently and through others, building strong partnerships with colleagues across Clinical Development, Medical & Science, Regulatory Affairs, Biostatistics and other functional areas. Medical & Science will be a particularly close partner, and together you will keep decisions timely and scientific quality high. The environment is dynamic, collaborative and highly science driven. We value diverse perspectives, because the strongest outcomes emerge when people with different experiences and expertise work together.

What you can expect here

You will be trusted to take ownership, make your voice heard and lead from the front, while informally guiding junior colleagues and growing alongside highly skilled, enthusiastic colleagues. You will work at the intersection of science, drug development and regulatory strategy, with room to keep building your expertise through relevant learning offerings and experience across functions.

Salary

For this role, the Annual Base Salary ranges from 847,000.00 to 1,245,100.00 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 commit to an inclusive recruitment process and equality of opportunity for all our job applicants.