Are you passionate about quality management and efficient global pharmacovigilance systems? 

LEO Pharma has embarked on a very ambitious journey to become the world’s preferred dermatology care partner – and that is why we need you. If you have experience in quality management, implementation and maintenance of global pharmacovigilance systems in the affiliates, then you may be our new colleague. In Global Safety Standards and Compliance, you will get the opportunity to make a significant difference for people with serious skin diseases all over the world.

In this position you will manage and coordinate the global pharmacovigilance (PV) compliance system by compilation and management of compliance data and documents for Global Safety (GS). In addition, you will manage and coordinate PV audits, inspections and deviations from the PV QMS, including the CAPA management. You will also be the involved in the PV intelligence process supporting the review of regulatory changes and ensuring an oversight and implementation of the key PV requirements.

Compliance Monitoring and Tracking

Managing a global tracking system to provide tracking and monitoring of safety reporting of ICSRs and aggregated safety reports

• Tracking and monitoring of PV KPI’s to enable analysis and calculation of the overall compliance performance, in order to meet PV regulatory obligations with timeframes
• Initiate corrective and preventive actions to avoid future non-compliances
• Assess, analyze and report the global PV compliance status and risks both within LEO Pharma and partners
• Flagging emerging issues or late reporting
• Developing and maintaining related GS QMS documents
• Contributing to QPPV oversight by providing updated lists to relevant PSMF annexes

GS Quality Management

• Handling and maintaining of the global PV Deviation system
• Handling and documentation of deviations, including quality assurance
• Overseeing PV deviations and reporting on related KPIs to QPPV and GS Management
• Guiding affiliates concerning deviation requirements and management o Managing and maintaining the periodic Quality Report to the QPPV and GS Management

Audits, Inspections and deviations

• Support to Global QA before, during and after PV audits
•  Coordinating GS support before, during and after inspections
• Supporting the management of local deviation reports and related CAPAs

Local pharmacovigilance requirements

• Ensure that national ICSR reporting requirements or other local safety related requirements are implemented in the global PV system
• Maintain and update GS oversight of products, local PV requirements, and split of responsibilities between Affiliates/Area offices and LEO Pharma partners

Other tasks

• Daily surveillance of GS mailbox in relation to Global Safety Standards and Compliance
•  Drive tasks of high complexity in internal or cross-functional projects
• Develop or improve procedures within area of responsibility

Your qualifications

• Pharmacist, other relevant Degree in Health Sciences or equivalent
• Extensive experience within the pharmaceutical industry
• Solid Pharmacovigilance knowledge
• Strong quality mindset
• Good communication skills
• Structured and detail oriented
• Able to set the direction and deliver results
• Independently make solve common issues and make improvements to systems within the area of responsibility
• Ability to guide and train other senior colleagues and managers
• Proficient in verbal and written English
• Good IT skills and experienced user of common Microsoft Office programs