Senior Medical Director, Global Safety (Remote)

Job summary

The Senior Medical Director for Global Safety serves as the primary safety expert for assigned products, overseeing pharmacovigilance activities and managing a team of Global Safety Physicians and Officers. This role is responsible for the overall safety profile and product-related decisions, ensuring compliance with global regulations.

Qualifications

• Extensive experience in pharmacovigilance and safety strategy development.
• Proven leadership skills in managing safety teams and projects.
• Strong understanding of regulatory requirements and safety submissions.

Responsibilities

• Provide strategic oversight for major regulatory safety submissions and responses.
• Lead the safety strategy and Benefit/Risk Management Process for assigned products.
• Chair safety governance meetings and participate in cross-functional projects.
• Develop and maintain core reference safety information and conduct benefit-risk evaluations.
• Represent Global Patient Safety in internal governance bodies for clinical studies.
• Develop signal detection strategies and evaluate safety findings.
• Ensure timely preparation and quality of periodic safety reports and risk management plans.

Skills

• Strong analytical and problem-solving skills.
• Excellent communication and presentation abilities.
• Ability to work collaboratively in a cross-functional environment.

Education

• Advanced degree in a relevant scientific or medical field.

Tools

• Familiarity with safety management systems and regulatory submission tools.