Safety Scientist CoE

Safety Scientist CoE

Daiichi Sankyo Europe

Munich or Remote, Germany

Roles and Responsibilities

Center of Excellence – Risk Management:

• Supports the development, implementation, and maintenance of global risk management activities and initiatives, ensuring alignment with regulatory requirements and internal standards;
• Actively drives close collaboration and regular interaction with Local Safety Officers (LSOs), Affiliate Management, and the QPPV Office;
• Works closely with the global Risk Management team within the CoE to ensure consistency, knowledge sharing, and alignment of practices across regions;
• Oversees day-to-day activities related to risk management processes and procedures, ensuring timely and compliant execution of deliverables;
• Develops, implements, and maintains standardized templates, tools, and procedures to enable efficient and consistent risk management practices across the organization.

Center of Excellence – Safety Surveillance:

• Supports the Pharmacovigilance Signal (PVS) tool and other global safety surveillance activities within the CoE, ensuring compliance with regulatory requirements and internal standards;
• Works closely with the global Safety Surveillance team within the CoE to ensure alignment, consistency, and effective knowledge sharing across regions.

Project Management:

• Leads and coordinates assigned projects, ensuring delivery in line with agreed timelines, scope, and quality expectations.

Education & Experience

Education:

• Bachelor's degree at minimum required; PharmD or PhD preferred.

Experience:

• 2–5 years of experience with an advanced degree.

Skills and additional Requirements

Competencies:

• Possesses strong GVP knowledge;
• Experience in risk management and safety surveillance;
• Strong communication skills;
• Experience in project management and working in a matrix environment;
• Knowledge of international, European, and PV laws;
• Fluent business English (oral and written).