Job Description

ATTENTION Eastern US region and EST or CST time zones

• Support creatio n of I ndividua l Case Sa f ety Reports ( I CS Rs ) of adverse drug reactions d eriving from cl i nical tr i als, spontaneous reporti n g systems and the literature; report i ng of ICSRs t o the competent a u thorities
• Support in the generatio n , processing, documenting, and tracking of follow-up req u ests
• E nsure ti mely and accurate C I OMS / Me d Watch del i verables
• Ass i st with database reco n cil i ation activit i es
• Scree n ing and doc um enta t ion of scientific l iterature regard i ng safety r e l evant pub l ications
• Documenta t ion of case processing on a company and a case leve l
• Support Medical Information intake, documentation, QC, and reconciliation services
• Hand l e customer inquiries o r comp l aints according to qua l ity assurance requ i re m ents
• Monitoring of inbound mailboxes
• Assist with case triage/guidance to case processing teams
• Ass i s t in the crea t ion of periodic r e p orts PSURs (Periodic Sa f ety Update Reports), DSURs (Development Sa f ety Update Reports), PADERs (Periodic Adverse Drug E xper i e n ce Reports), risk management plans and signa l de t ection reports
• Lead Client and internal operational meetings to ensure quality, compliance, and timelineness
• Contribute to/ review QA documents suc h as Working In st ru ctions, SOPs, Worki ng Procedures , templates, project metafiles, etc. for PharmaLex pharmacovigilance projects
• Organize and perform training of the above-mentioned QA documents
• Perform quality control tasks, e.g. ICSR processing quality checks, and other project-specific quality checks
• Support initiation and closure of any project-related deviation and CAPA issues
• Prepare for and participate in internal and external audits/inspections
• Other duties as assigned

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law.

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