Job Summary

A biotechnology company needs applicants for an opening for a Remote Pharmacovigilance Operations Director.

Core Responsibilities Include:

• Overseeing the company’s drug safety and pharmacovigilance operations process.
• Managing compliance with standard operating procedures and compliance areas
• Participating in oversight of ongoing clinical trials and in the preparation of new drug application

Qualifications Include:

• BS/MS/RN and with 12+ years of experience or PharmD, PhD, MD
• 7+ years of experience in the pharmaceutical industry
• Solid knowledge of global regulations governing pharmacovigilance
• Strong working knowledge of FDA and international adverse event reporting regulations
• Strong working knowledge of case management and processing
• Experience in using ARGUS or other safety databases