General

• Develop, qualify and improve global transport and cold chain distribution solutions compliant with GDP
• Provide practical guidance on cold chain requirements as a subject matter expert
• Lead transport validation and qualification activities, including protocols, performance qualifications, reports, periodic reviews and risk assessments
• Support audits, inspections and assessments
• Support qualification and ongoing assessment of logistics suppliers and transport solutions
• Define and address distribution and qualification requirements for new product introductions and distribution lanes
• Manage and assess temperature excursions using relevant stability data when required
• Own deviations, change controls and CAPAs related to distribution and cold chain activities
• Investigate root causes, coordinate stakeholder actions and follow through on implementation and effectiveness
• Translate recurring issues and operational insights into improvements
• Assess and implement global cold chain monitoring and data management systems
• Develop and maintain dashboards, KPIs and analytics frameworks
• Analyze data to identify trends and emerging risks and prepare actionable insights for management reviews and governance meetings
• Collaborate with Digital, IT, Quality and Supply Chain to improve digital platforms, automate reporting and strengthen data quality
• Evaluate and support AI-enabled solutions, predictive analytics, intelligent automation, digital simulation and connected monitoring technologies
• Support data governance, data integrity and validation requirements for GxP-relevant digital systems

Global Distribution Validation – Cold Chain Specialist

• Perform key medical information contact center services
• Provide timely, accurate, and balanced responses to unsolicited requests for information to HCPs and patients using Biomapas or customers’ Medical Information System
• Analyze and interpret scientific data to update or develop comprehensive, balanced, credible and accurate response documents meeting applicable laws and procedures
• Exchange customer insights and scientific information with internal & external partners
• Ensure compliant execution of all MI and PV operational activities at high level of quality
• Engage in timely handling and reporting of safety information and product quality complaints
• Perform local operations and ensure compliance with safety regulations and procedures
• Review local literature and act as a local safety officer serving as the main contact for safety matters with authorities and customers, as applicable

General jobs in Denmark

Global Distribution Validation – Cold Chain Specialist

Medical Information and Pharmacovigilance Specialist – Nordics