Student Worker - Drug Safety & Pharmacovigilance Compliance

1w1 week ago

Genmab

Copenhagen, DK · Part-time · DKK 200,000 – DKK 280,000

About this role

At Genmab, we develop antibody products and groundbreaking antibody medicines that change lives and the future of cancer treatment. The Global Drug Safety & Pharmacovigilance Compliance team supports safety-related processes, systems, and documentation per GxP requirements across the product lifecycle. Join as a student worker to contribute to clinical development and post-marketing safety activities.

This role offers hands-on administrative support in a highly engaged compliance team. You will handle operational tasks ensuring compliance with standards and timelines in a global biotech environment. Gain exposure to both clinical and post-marketing operations while developing professional skills.

Our people are compassionate, candid, purposeful, innovative, and rooted in science. We create a workplace valuing unique contributions and driving patient-focused solutions. We pursue big ambitions with care and have fun along the way.

If this inspires you, join our purposeful team transforming serious diseases. Support the operational backbone of drug safety in an authentic, determined culture. Build extraordinary futures together at Genmab.

Requirements

Currently pursuing a bachelor’s degree in natural sciences, medical or health sciences, or IT or similar – second to fourth semester
Proficient in Microsoft 365 (Outlook, Excel, PowerPoint, SharePoint, etc.)
Comfortable navigating various IT systems
Fluent in English, both written and spoken
Service-minded and detail-oriented
Ideally prior experience from another student job
Strong interest in administrative support within Drug Safety and Pharmacovigilance

Responsibilities

Upload and manage clinical trial safety documentation in the Trial Master File (TMF); assist with system support
Draft onboarding documents and manage signature process for training plans and GxP-relevant files
Enroll employees in training and maintain the department dossier
Maintain SharePoint sites, arrange travel, and provide general administrative support
Request, grant, and maintain access to relevant drives and systems
Maintain and update distribution lists
Monitor Flash Reports in Veeva Quality and shared mailboxes
Coordinate and arrange GCP training and DIA modules; assign training in Veeva Quality
Support record retention activities, including document clean-up, archiving, and transfer per GxP requirements