Executive Medical Director, Drug Safety

Position Overview

The Executive Medical Director will lead the evaluation and interpretation of safety data from diverse sources, including clinical trials, spontaneous and solicited reports, aggregate data, and literature. This role requires a physician with strong analytical skills to interpret drug safety information and contribute to the development of safety reports (e.g., clinical safety assessments). The ideal candidate will possess up-to-date medical expertise, a deep understanding of pharmacovigilance regulations, and best practices in safety surveillance and risk management.

About You

You are an experienced physician with a robust background in drug safety and pharmacovigilance. Your expertise spans signal detection, risk management, and regulatory compliance, enabling you to analyze complex safety data with confidence. You bring a strategic approach to health authority interactions, safety report authorship, and proactive safety planning across clinical programs.

Your leadership skills allow you to effectively manage cross-functional teams and external partners, ensuring compliance with global regulatory standards. You are detail-oriented, forward-thinking, and thrive in dynamic environments. Your proficiency with safety databases, MedDRA, and evolving pharmacovigilance regulations supports your commitment to patient safety. Above all, you are a collaborative communicator who can clearly convey complex safety concepts and drive continuous improvement within a growing organization.

Key Responsibilities

• Oversee safety content in clinical documents, including study protocols, reports, Investigator's Brochures (IB), product labels, and SUSARs.
• Serve as the safety representative in regulatory interactions (e.g., FDA).
• Monitor safety signals and trends, and manage emerging safety concerns proactively.
• Develop and author responses to health authority inquiries.
• Lead medical evaluation of aggregate safety data, including signal detection and ad hoc assessments.
• Conduct medical reviews of serious adverse events from clinical trials.
• Support the development and review of safety sections in clinical documents (e.g., DSURs, final study reports, IBs).
• Lead the creation and implementation of Risk Management Plans and assess their effectiveness.
• Ensure timely communication of safety issues to relevant stakeholders.
• Ensure all medical safety activities comply with applicable regulations and internal standards.
• Stay current with global regulatory requirements, including those from the FDA and EMA.
• Mentor and support the professional development of department staff.

Qualifications

• MD or DO with 10+ years of relevant experience.
• U.S. medical board certification (or equivalent international certification).
• Strong scientific and analytical foundation with deep knowledge of pharmacovigilance practices and regulations.
• Proficiency with validated safety databases (preferably ARGUS) and MedDRA.
• In-depth understanding of U.S. and international pharmacovigilance regulations, GCP, and ICH guidelines.