Pharmacovigilance Configurations Expert

4 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time
About Genmab

Genmab is an international biotech company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases. We are committed to building extraordinary futures together and transforming the lives of patients through innovative cancer treatment.

The Role

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. This role requires strong collaboration and problem-solving skills, as well as experience with Argus or other PV databases.

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.
Qualifications
  • 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.


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