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Pharmacovigilance Principal Specialist

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Life Science Talent

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Location:
Denmark , Søborg

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Category:
Health and Beauty

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Contract Type:
Employment contract

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Salary:

Not provided
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Job Description:

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. 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. 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.

Job Responsibility:

  • 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)

Requirements:

  • 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

Nice to have:

PhD and/or a degree in Drug Development or Pharmacovigilance is an advantage

Additional Information:

Job Posted:
May 03, 2026

Expiration:
May 03, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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