Safety Operations Outsourcing Specialist

Category: Reg Affairs & Safety Pharmacovigilance

Location:Søborg, Capital Region of Denmark, DK

• Collaborate closely with internal stakeholders to define project requirements, timelines, and deliverables.
• Together with the team members across the value chain you will ensure the outsourcing model is in compliance with regulatory requirements, internal quality processes, and industry standards.
• Manage relationships with external vendors and performance monitoring against established metrics and KPIs, and develop improvement plans as needed. You will continuously evaluate and improve vendor management processes and tools to increase efficiency and effectiveness.
• Being responsible for identifying and mitigating risks associated with outsourcing Safety Operations activities and provide regular updates to Safety Operations management on vendor performance and projects status.
Assuming responsibility, communicating information and taking action will be essential parts of your workday.

• A MSc degree in Life Science.
• Strong experience within the pharmaceutical industry with a thorough understanding of the R&D value chain.
• Experience working together with or within CROs.
• Strong experience and understanding of processes and regulatory requirements within pharmacovigilance and clinical trial regulation.
• Proven project management experience, background in leading cross functional projects would be an asset.