Senior Manager

1 week ago

Copenhagen, Copenhagen, Denmark Genmab Full time

Job Description

We are looking for an experienced Senior Manager - Drug Safety Systems to join our team at Genmab. As a key member of our Global Drug Safety and Pharmacovigilance (GDS&PV) unit, you will be responsible for the configuration, maintenance, and optimization of safety systems, including Argus.

Key Responsibilities:

  • Configure and maintain safety systems to ensure accuracy, timeliness, and scalability.
  • Collaborate with internal and external stakeholders to understand requirements and recommend scalable solutions.
  • Serve as a liaison between GDS&PV, IT, and other functions for technical issues.
  • Author or review User Requirements Specification (URS) and User Acceptance Test (UAT) scripts during safety system implementation and upgrade.
  • Generate complex reports from the safety database using SQL.
  • Partner with Clinical Data Management and the Pharmacovigilance service provider to optimize retrieval of safety data from Electronic Data Capture (EDC).
  • Debug complex problems with safety systems and applications in partnership with IT and/or system vendors.
  • Support during audits and inspections.
  • Develop and maintain GDS&PV departmental Standard Operating Procedures and Working Instructions.
  • Perform other safety system-related activities as needed or requested by supervisor.

What We Offer

As a Senior Manager - Drug Safety Systems, you will have the opportunity to work with a talented team of professionals who share your passion for transforming the lives of patients through innovative cancer treatment.

Requirements and Qualifications

  • 6+ years of experience in the biotechnology or pharmaceutical industry with a focus on Drug Safety/Pharmacovigilance; 3+ years in safety database management.
  • Experience with Argus or other PV databases is essential.
  • Good knowledge of clinical and post-marketing (PV) domains.
  • Strong collaboration skills with team members.
  • Ability to work in a fast-paced environment.
  • Strong hands-on SQL skills.
  • Good knowledge of PV-related health authority regulations.
  • Prior experience with writing/reviewing UAT/URS/Functional Specification preferred.
  • Knowledge of analytical tools (like Business Objects, Spotfire) preferred.
  • Experience and interest in Artificial Intelligence (AI), NLP, and Machine Learning skills are preferred.

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