Pharmacovigilance Principal Specialist

Does it excite you to work with drug safety, and do you have experience with safety strategies and safety surveillance spanning early phases of clinical development through regulatory dossier preparations for NDA/MAA? If this sounds like you, and you are ready to take on a broad area of responsibilities, then you could be our new colleague.

Your new position
In this role, clinical safety will be shared with an experienced colleague, and the position will carry clinical safety responsibility for an early development phase project in inflammatory diseases. The role contributes to safety strategy, proactive surveillance, and cross-functional decision-making across the clinical program. The position offers broad exposure from early clinical phases through key regulatory interactions and submission activities.

We offer exciting responsibilities:

• Represent Patient Safety in cross-functional project teams
• Represent Patient Safety in meetings with regulatory authorities
• Develop the safety surveillance strategy for assigned project/clinical trials
• Execute signal detection activities to support evaluation and decisions by the internal Safety Committee
• Perform safety analyses and aggregated reporting, and contribute to safety sections of regulatory submission dossiers (NDA/MAA)
• Prepare Risk Management Plans (RMP) / Risk Evaluation and Minimization Strategies (REMS)

Your profile
The ideal candidate demonstrates high ethical standards and a strong quality mindset. The role requires a collaborative, proactive approach and a clear motivation to continuously develop professionally. Success depends on the ability to communicate effectively and build strong working relationships with both internal and external stakeholders.

• Master’s degree in Medicine (MD), Pharmacy, or Human Biology
• Minimum 7 years of hands-on experience in clinical safety/pharmacovigilance applied to safety surveillance
• Experience developing and executing safety strategies and surveillance activities across clinical development
• Strong capabilities in signal detection and benefit-risk evaluation to support governance decisions
• Experience with aggregated safety analyses/reporting and contributions to regulatory dossiers (NDA/MAA)
• Experience with RMP and/or REMS; PhD and/or a degree in Drug Development or Pharmacovigilance is an advantage

Your new team
Patient Safety in Zealand Pharma is a strong and cohesive team of highly skilled Physicians, Pharmacists and Biologists who work in the matrix project organization within Development. Thus, you will have the opportunity to make very important contributions to Zealand clinical projects and to our team, in an environment based on respect and collaboration.

Let's bond and be bold
We have a unique culture, characterized by excellent teamwork and strong engagement across the organization. And we want you to help us strengthen this culture.

Making bonds is at the core of everything we do. From discovering and developing the best new peptide drugs for patients, to engaging with our partners or connecting with each other. We bond through curiosity and playfulness as a team, allowing ourselves to challenge common thinking and drive future innovation. Join us and let's bond and be bold.

Interested in bonding with us? Then please apply no later than May 3, 2026, or as soon as possible. The applications will be reviewed as they come in. While a cover letter is not required, please include a few sentences in your CV explaining your motivation for applying.

For further information, please contact Senior Director, Head of Patient Safety, Liliana Cristina Hansen: lch@zealandpharma.com.

We are committed to an inclusive recruitment process and welcome applications from all job applicants.

About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on advancing medicines for obesity and metabolic health. Combining more than 25 years of peptide R&D expertise with a proprietary data platform that leverages advanced datadriven and AI/ML approaches, Zealand Pharma aims to lead a new era in obesity and metabolic health. To date, more than ten Zealand Pharma invented drug candidates have entered clinical development, of which two products have reached the market and three candidates are in late-stage development. The Company has collaborations with global pharmaceutical and biotechnology partners for research, development, and commercialization. Founded in 1998, Zealand Pharma is headquartered in Copenhagen, Denmark, with a U.S. presence in Boston, Massachusetts. Learn more at www.zealandpharma.com.

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