Associate Director, Pharmacovigilance Vendor Management

Job summary

This role involves leading pharmacovigilance activities for Organized Data Collection programs related to marketed products, ensuring compliance with global and local regulations. The position is based in Hellerup, Denmark, and requires collaboration with cross-functional teams to establish and oversee PV processes.

Qualifications

• Relevant academic degree, preferably a Bachelor’s in a health-related field.
• Minimum of 8 years of experience in Pharmacovigilance within the pharmaceutical industry.
• Expert knowledge of FDA safety regulations, ICH Guidelines, and GVP requirements.

Responsibilities

• Lead pharmacovigilance activities throughout the lifecycle of Organized Data Collection programs.
• Partner with internal stakeholders to establish PV processes in various programs.
• Provide strategic input on vendor contracts and AE handling processes.
• Ensure oversight and performance monitoring of service providers/vendors.
• Collaborate with various departments to maintain compliant PV practices.
• Develop and deliver PV training materials and sessions.

Skills

• Strong analytical skills and a proactive attitude.
• Ability to work independently and as part of a team.
• Competence in navigating uncertainty and adapting to changing priorities.

Education

• Bachelor’s degree in a health-related discipline preferred.

Tools

• Familiarity with digital platforms and compliance monitoring tools is advantageous.