Job Summary

A biopharmaceutical company is in need of a Remote Safety and Pharmacovigilance Call Center Specialist I.

Core Responsibilities Include:

• Performing inbound and handling outbound phone calls, to collect initial and follow-up information
• Identifying correct questions to be asked/information to be obtained according to the context of the call and project-specifications
• Methodically collecting and documenting adverse event /safety information, including product/device usage details, concomitant medications, medical history, and event details

Skills and Requirements Include:

• Bachelor’s Degree in nursing, licensed or registered nurse, pharmacist or an equivalent combination of education and experience
• Experience with safety database systems and knowledge of medical terminology preferred and/or Call Center experience preferred
• Demonstrated good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance preferred
• Demonstrated detail orientation with high degree of accuracy and ability to meet deadlines
• Ability to respond to medical inquiries, to the extent required/allowed per project
• Ability to ensure all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File