System Manager (Drug Safety, Hellerup)

Job summary

This role involves managing systems related to drug safety, focusing on adverse event intake and signal detection processes. The System Manager will ensure system stability and functionality while providing excellent technical solutions and user experiences.

Qualifications

• Relevant academic degree, preferably a Master’s, in Engineering, System Management, or a related technical field.
• Minimum of 5 years of experience with drug safety systems in a pharmaceutical context.
• Strong understanding of Drug Safety processes and systems.
• Experience with SaaS vendors and GxP processes for system management.

Responsibilities

• Serve as the technical expert for intake and signal detection systems.
• Translate business needs into specifications for SaaS application configurations.
• Implement configurations directly or collaborate with vendors for implementation.
• Ensure systems are validated and inspection-ready.
• Prepare documentation for audits and inspections.
• Oversee system support and act as an escalation point for issues.
• Maintain operational oversight of vendors.
• Facilitate end-user training and user groups.
• Propose and implement improvements for automation and data flows.
• Assist with documentation and validation of solutions.
• Collaborate with IT product teams to solve problems and deliver solutions.

Skills

• Strong analytical skills and a proactive attitude.
• Ability to collaborate effectively in complex environments.
• Strong team player with an entrepreneurial mindset.

Education

• Master’s degree or equivalent in a relevant technical field.

Tools

• Familiarity with SaaS solutions and drug safety systems.