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Safety Data Management Expert

3 weeks ago

Copenhagen, Copenhagen, Denmark Genmab Full time

At Genmab, we're committed to building extraordinary futures together by developing innovative therapies that transform the lives of patients. Our people are caring, candid, and impact-driven, and our business is rooted in science.

About Us

We're an international biotechnology company specializing in the invention and development of human antibody therapeutics for cancer treatment and other serious diseases.

The Role

You will become part of our Global Drug Safety and Pharmacovigilance unit where you'll be responsible for safety data management activities including configurations, maintenance of safety systems, generation of reports, and implementation and validation of safety solutions.

  • Configure and maintain safety systems ensuring accurate, timely, and scalable results.
  • Work closely with internal and external users to understand requirements and recommend solutions.
  • Serve as a liaison between GDS&PV, IT, and other functions for technical issues.
  • Author or review URS and UAT scripts during safety system implementation and upgrade.
  • Generate complex reports from the safety database using SQL.
  • Collaborate with Clinical Data Management and the Pharmacovigilance service provider to optimize retrieval of safety data.
  • Debug complex problems with safety systems and applications in partnership with IT and/or system vendors.
  • Support during audits and inspections.
  • Prepare and maintain departmental Standard Operating Procedures and Working Instructions.
  • Perform other safety system-related activities as needed or requested by supervisor.