Director, Medical Safety

Our client, a leader in the Pharmaceuticals & Biotech space, is seeking a Director, Medical Safety to own the medical safety function across development and post‑marketing activities. This remote, US‑based role partners closely with clinical development, regulatory, and labeling stakeholders to ensure safety information is accurate, consistent, and compliant.

Responsibilities

• Lead, mentor, and develop a team of Pharmacovigilance Scientists.
• Allocate resources effectively across multiple products and programs.
• Oversee routine and ad‑hoc signal detection for investigational and marketed products.
• Prepare and maintain core Risk Management Plans (RMPs) and other safety documents.
• Ensure consistency across regulatory information and labeling.
• Oversee the quality of aggregate safety reports and provide strategic guidance on safety assessments.
• Implement and optimize AI‑enabled tools for pharmacovigilance activities.

Qualifications

• Master's or PhD in Pharmacy, Pharmacology, Life Sciences, Nursing, Public Health, or a related field.
• 10+ years of experience in pharma/biotech, including 5+ years in people‑management roles.
• Experience supporting clinical development and post‑marketing pharmacovigilance activities.
• Expertise in signal detection and signal management.
• Strong authoring skills for Risk Management Plans (RMPs).
• Thorough knowledge of ICH guidelines, FDA, and EMA regulations.
• Demonstrated leadership and strategic project‑management skills.

Benefits

• Comprehensive medical, dental, and vision coverage, plus mental‑health support.
• Generous paid time off and flexible work schedules.
• 401(k) plan with a competitive company match.
• Participation in an employee stock purchase plan.
• Access to professional development opportunities through a learning institute.
• Employee resource groups and recognition programs for community engagement.

Pay

$185,000 – $252,500 annually