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Pharmacovigilance Specialist (AM) Jobs

New Haven, Connecticut

<p> Pharmacovigilance Specialist (AM) AP7124737</p><p> New Haven, CT 06510</p><p> 12 Month Contract</p><p> *** No Subcontractors ***</p><p> Duties:</p> Does need some Argus or other Safety Databases but Argus would be better CAPA not that important not aresponsibility Study base role People Skills Project Managementskills No case processing involved but you need to be able review a narrative but need to look in the safety database to understand what the team is doing. Must have Phase studies and must have Pharmacovigilance Participates in study teams/representative for PV operations Authors Safety Documents including Study Safety Reporting Plans Responsible for SAE Reconciliation Experienced with Argus Database Global regulatory reporting/compliance Understanding of MedDRA coding conventions Ensures follow-up & query process Vendor oversight Aggregate Safety Reports 5+ Years of Experience Specific pharmacovigilance experience (drug safety) Project management CAPA experience Excellent communication skills<p> Education:</p><p> Advanced HCP degree (ie: BS Nursing, Masters degree in health related field, PharmD)</p>

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