Student Worker, Global Drug Safety & Pharmacovigilance Compliance

At Genmab we are dedicated to building extranotordinary futures together by developing antibody products and groundbreaking knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create champion and maintain a global workplace where individuals unique contributions are valued and drive innovative solutions to meet the needs of our patients care partners families and employees.

Our people are compassionate candid and purposeful and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes our work is incredibly serious and impactful but we have big ambitions bring a ton of care to pursuing them and have a lot of fun while doing so.

Does this inspire you and feel like a fit Then we would love to have you join us!

The Role

Are you a bachelors student with a strong interest in administrative support and eager to gain hands-on experience within Drug Safety and Pharmacovigilance Join Genmabs Global Drug Safety & Pharmacovigilance (GDS&PV) Compliance team as a student worker and contribute to the operational backbone supporting both clinical development and post-marketing safety activities!

This is a unique opportunity to support a highly engaged and experienced compliance team while developing your professional skills in a global biotech environment. GDS&PV Compliance is responsible for supporting and overseeing safety-related processes systems and documentation in accordance with GxP requirements ensuring compliance throughout the product lifecycle from early clinical development through post-marketing.

Responsibilities

In this role you will support the GDS&PV Compliance Team. Your tasks will include:

• Sponsor TMF & record management: Upload and manage clinical trial safety documentation in the Trial Master File (TMF); assist with system support.

• Onboarding & training coordination: Draft onboarding documents manage the signature process for training plans and other GxP-relevant dossier files ensuring compliance with applicable standards and timelines. Enroll employees in training and maintain the department dossier.

• Operational support: 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

• Monitoring of Flash Reports in Veeva Quality shared mailboxes

• Coordinate and arrange GCP training and DIA modules

• Assign Training (direct assignments) in Veeva Quality

• Support record retention activities including document clean-up archiving and transfer in accordance with applicable GxP requirements

• Sponsor TMF & record management: Upload and manage clinical trial safety documentation in the Trial Master File (TMF); assist with system support.

Requirements

We are seeking a service-minded and detail-oriented student who meets the following criteria:

• Currently pursuing a bachelors degree in natural sciences medical or health sciences or IT or similar you are on second to fourth semester.

• Proficient in Microsoft 365 (Outlook Excel PowerPoint SharePoint etc.) and comfortable navigating various IT systems.

• Fluent in English both written and spoken.

• Ideally prior experience from another student job.

About You

• You are genuinely passionate about our purpose

• You bring precision and excellence to all that you do

• You believe in our rooted-in-science approach to problem-solving

• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds

• You take pride in enabling the best work of others on the team

• You can grapple with the unknown and be innovative

• You have experience working in a fast-growing dynamic company (or a strong desire to)

• You work hard and are not afraid to have a little fun while you do so!

Locations

Genmab maximizes the efficiency of an agile working environment when possible for the betterment of employee work-life balance. Our offices are crafted as open community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether youre in one of our office spaces or working remotely we thrive on connecting with each other to innovate.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years its hard-working innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational quantitative and data sciences resulting in a proprietary pipeline including bispecific T-cell engagers antibody-drug conjugates next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030 Genmabs vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.

Established in 1999 Genmab is headquartered in Copenhagen Denmark with international presence across North America Europe and Asia Pacific. For more information please visit and follow us on LinkedIn and X.

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice ().