Pharmacovigilance QC Specilalist 12-month contractHybrid in Plainsboro, NJJob Requirements: • In-depth pharmacovigilance case handling from case intake to submission of Individual Case Safety Reports (ICSRs)• Extensive quality control of ICSRs to ensure compliance to internal and external health authority regulations (21 CFR FDA PostMarketing). • Experience and familiarity working in safety databases (e. g. Argus)• Identifies nonconformance and communicates via feedback or escalation as needed. Qualifications: • Education Level: Minimum Bachelor’s degree, HCP degree is required e. g. , pharmacist or nurse; advanced degree preferred• Experience Level:
3+ Years of in Pharmacovigilance Case Processing• Analytical thinker with proficiency working with safety databases• Proficiency in MS Outlook, Excel, Word,• Excellent written and verbal communication skills
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