Medical Reviewer - ICSR

About the role

Medical Reviewer is the key contact person for assigned clinical development or marketed products, responsible for safety strategy and major safety deliverables, including both early and late-stage development, as assigned. He/she is accountable for safety and risk management activities for one or more assigned products.

What you'll do

• Analyzes, reviews, and interprets safety data, both non-clinical and clinical
• Performs medical review of ICSRs, and other drug safety information from multiple sources, including clinical trials, spontaneous and solicited reports
• Provides technical and medical expertise in medical assessment of causality of Individual Case Safety Report (ICSR) as necessary
• Contributes to the generation of aggregate safety reports including development safety update reports, periodic benefit risk evaluation reports
• Contributes to the development of Standard Operating Procedures, Working Instructions and other guidance documents

What you need

• Pharmacovigilance
• Clinical research
• CRO
• Regulatory affairs
• SOP writing
• Communication