Senior Data Management Specialist

2 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time
About Us

At Genmab, we're committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. Our people are caring, candid, and impact-driven, and our business is innovative and rooted in science.

The Job Description

This role is hybrid, requiring you to work from our HQ in Copenhagen, Denmark 60% of the time. As a Senior Manager, Safety Data Management, you will become part of the Global Drug Safety and Pharmacovigilance (GDS&PV) unit, where you will be responsible for safety data management activities, including configurations and maintenance of safety systems, generation of complex ad-hoc reports, and implementation and validation of safety systems and solutions.

Key Responsibilities
  1. Configure and maintain safety systems (Argus) to ensure accuracy, timeliness, and scalability.
  2. Work with internal and external stakeholders to understand requirements and provide scalable solutions.
  3. Collaborate with IT and other functions to resolve technical issues.
  4. Develop and review user documentation for safety system implementation and upgrade.
  5. Generate complex reports from the safety database using SQL.
  6. Collaborate with Clinical Data Management and the Pharmacovigilance service provider to optimize safety data retrieval.
  7. Debug complex problems with safety systems and applications.
  8. Support audits and inspections.
  9. Develop and maintain GDS&PV departmental Standard Operating Procedures and Working Instructions.
Requirements
  • 6+ years of experience in the biotech/pharmaceutical industry with a focus on drug safety/pharmacovigilance; 3+ years in safety database management.
  • Experience with Argus or other PV databases is required.
  • Good knowledge of clinical and post-marketing domains.
  • Strong collaboration and problem-solving skills.
  • Ability to work in a fast-paced environment.
  • Strong SQL skills.
  • Good knowledge of PV-related health authority regulations.
  • Prior experience with writing/reviewing user documentation preferred.
About You
  • You are passionate about our purpose and genuinely care about our mission to transform lives.
  • You bring rigor and excellence to all that you do.
  • You are a collaborative team player.
  • You are determined to do and be your best.
  • You are not afraid to innovate.
  • You have experience working in a dynamic company.
  • You work hard and have a good sense of humor.


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