Job Summary

A company that conducts discovery research, clinical development and regulatory affairs needs applicants for an opening for a Remote Safety Operations Associate Director.

Core Responsibilities of this position include:

• Overseeing the proper and timely collection and reporting of AE information from all sources
• Assisting in the preparation and management of aggregate safety reports
• Performing medical review of AEs/SAEs from clinical trials, interfacing with reporters as needed

Position Requirements Include:

• Health science degree: Nursing,  RPH, PharmD, PA or MD
• Minimum of 7 years of experience in the pharmaceutical industry or CRO
• 5 years in drug safety, pharmacovigilance and risk assessment or relevant experience
• Experience in the management of safety information originating from clinical trials
• Experience and working knowledge of Good Pharmacovigilance Practices
• Knowledge of U.S. and International Regulatory Reporting Requirements for Product Safety