Associate Director, Pharmacovigilance (Biopharmaceutical, Hellerup)

Job summary

This role involves leading global pharmacovigilance (PV) activities and ensuring compliance with local and global safety processes within a biopharmaceutical context. The position is based in Hellerup, Denmark, and requires collaboration with various stakeholders to maintain high standards in patient safety.

Qualifications

• Relevant degree in life sciences
• Over 7 years of experience in post-marketing pharmacovigilance and quality processes
• Solid experience with Affiliate PV systems from both local and global perspectives
• Strong knowledge of EU GVP legislation, FDA, and other major regulatory authority PV requirements
• Proficiency in English (written and spoken) and MS Office; experience with Veeva systems is a plus

Responsibilities

• Lead global PV oversight for affiliates, ensuring compliance with local requirements and integration with global systems
• Define and maintain global and local PV procedural strategies
• Establish and oversee local literature monitoring for quality alignment
• Drive PV readiness for product launches across affiliates
• Lead audits and inspection activities for affiliates
• Oversee PV deviations and quality management related to affiliates
• Collaborate with PV Alliance Management Lead for consistent processes
• Support globalization initiatives and QMS activities as needed

Skills

• Strong team player with a positive, can-do attitude
• Entrepreneurial mindset with the ability to thrive in a dynamic environment
• Self-driven with excellent communication skills
• Flexibility to work overlapping hours with colleagues in different time zones

Education

• Degree in life sciences or related field

Tools

• MS Office, Veeva systems (preferred)