Medical Safety Lead

Job Summary

A company is looking for a Medical Safety Lead to provide strategic medical safety leadership and oversight.

Key Responsibilities

• Lead and contribute to safety signal management and benefit-risk assessment activities
• Ensure high-quality safety contributions for regulatory submission documents and clinical documents
• Develop and execute Risk Management Plans (RMPs) and support safety training initiatives

Required Qualifications, Training, and Education

• MD degree or equivalent required
• At least 10 years of relevant experience in the pharmaceutical/biotech industry, with 7 years in pharmacovigilance/drug safety
• Proven leadership skills in a global and intercultural environment
• Experience with authoring complex documents and contributing to regulatory submissions
• Knowledge of relevant pharmacovigilance regulatory requirements and adverse event reporting systems