Associate Medical Director, Drug Safety and Pharmacovigilance - Remote

Overview

The Associate Medical Director, Drug Safety and Pharmacovigilance is responsible for the medical assessment of Individual Case Safety Reports (ICSRs) and other drug safety information, providing interpretation and summaries of drug safety information, and collaborating with safety teams.

In Short

• Provide medical expertise in the assessment of ICSRs.
• Contribute to the generation of aggregate safety reports.
• Contribute to signaling and safety surveillance processes.
• Serve as a medical resource for clinical trial protocols.
• Contribute to Risk Management Plans and updates.
• Develop Standard Operating Procedures and guidance documents.
• Provide safety and pharmacovigilance training programs.
• Collaborate cross-functionally to ensure pharmacovigilance input.
• Support other pharmacovigilance and drug safety responsibilities.

Requirements

• 4+ years’ experience in Drug Safety / Pharmacovigilance.
• Healthcare degree required; Medical Degree (MD) preferred.
• Good knowledge of US and EU drug safety regulations.
• Experience with medical drug safety assessments.
• Proficiency with medical review of ICSRs.
• Experience with safety data collection and interpretation.
• Experience with preparation of aggregate reports.
• Experience with responses to Regulatory Authorities.
• Ability to build relationships and collaborate across disciplines.
• Excellent verbal, written, and presentation skills.

Benefits

• Equal employment opportunities.
• Collaborative work environment.
• Opportunity to work with experienced professionals.
• Engagement in meaningful work addressing cancer treatment.