Pharmacovigilance Scientist

Job Summary

A company is looking for a Director, Pharmacovigilance Scientist.

Key Responsibilities

• Provide life-cycle support for assigned products and participate in clinical study team meetings
• Represent pharmacovigilance as a lead in cross-functional teams and perform ongoing quality reviews of safety data
• Author and prepare safety documents and collaborate with clinical teams on risk management activities

Required Qualifications

• MS, PhD, or PharmD
• At least 5 years of experience in pharmacovigilance or clinical research safety
• Experience in immunology and oncology, with knowledge of CART-cell therapy preferred
• Familiarity with safety system databases and regulatory requirements
• Experience in authoring aggregate safety reports (DSURs)