Review and approve post-marketing Individual Case Safety Reports (lCSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. This includes coding, assessment of seriousness, expectedness, and company causality, as well as writing of company comment, follow-up questions and analysis of similar events.
Job listings
$228,200–$358,600
USD/year
US
24w PTO
Serves as Global Safety Lead and the Company-wide patient safety expert for assigned pharmaceutical / biological / drug-device combined products, accountable for the safety strategy and major safety deliverables for each assigned product. Leads GPSE Safety Team and Safety Management Team for assigned compounds and products. Manages cross-functional assessment of benefit-risk profile and communication of safety information for assigned compounds and products.
$228,200–$358,600
USD/year
US
24w PTO
Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert for assigned pharmaceutical / biological / drug-device combined products, accountable for the safety strategy and major safety deliverables for each assigned product. Leads GPSE Safety Team (GST) and Safety Management Team (SMT) for assigned compounds and products. Manages cross-functional assessment of benefit-risk profile and communication of safety information.