Global Safety Lead - Remote

Overview

The Global Safety Lead is responsible for assessing medical safety data, developing safety strategies, and collaborating with various stakeholders to ensure the safe use of products.

In Short

• Lead assessment of medical safety data for assigned products.
• Develop and execute safety signaling and benefit-risk management strategies.
• Collaborate with internal and external stakeholders for safety communications.
• Perform safety signal management and benefit-risk assessment activities.
• Prepare safety sections of regulatory submission documents globally.
• Oversee the preparation of periodic safety reports.
• Provide medical safety support for regulatory inquiries.
• Lead cross-functional teams in safety data reviews.
• Support pharmacovigilance training and awareness activities.
• Contribute to the development of safety governance structures.

Requirements

• MD degree or equivalent required.
• At least 7 years of experience in the pharmaceutical/biotech industry.
• Minimum 5 years in pharmacovigilance/drug safety.
• Experience in clinical practice or academic medicine is preferred.
• Strong scientific and analytic skills.
• Excellent presentation and communication skills.
• Proficiency with Microsoft Office.
• Fluency in written and spoken English.
• Knowledge of pharmacovigilance regulatory requirements.
• Experience with authoring complex documents.

Benefits

• Opportunity to work in a global immunology company.
• Contribute to innovative antibody-based medicines.
• Collaborate with leading academic researchers.
• Engage in cross-functional teams and initiatives.
• Work in a fast-paced environment with dynamic challenges.