Senior Associate Pharmacovigilance

divh2Senior Associate Pharmacovigilance/h2pA Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing./ph3Job Description/h3pOur direct Client is looking to hire Senior Associate Pharmacovigilance Position/ppPrincipal Duties/pulliCollaborates with internal departments on implementation of quality principles and regulatory requirements related to Good Pharmacovigilance Practice (GVP)/liliCoordinates PV-related aspects of inspection readiness activities/liliAssists in addressing audit findings and development of Corrective and Preventative Actions (CAPAs)/liliParticipates in development and reporting of compliance metrics related to GVP activities/liliConducts effectiveness checks and internal assessments of current processes and procedures to identify potential process improvement opportunities/liliAssist in hosting of regulatory inspections related to PV/liliApplies departmental SOPs and participates in the development of departmental SOPs, as appropriate/liliResponsible for maintenance, update, and change control of the Pharmacovigilance System Master File (PSMF)/liliMonitors commitments from internal audit and regulatory inspection findings/liliPerforms late case investigations and writes delayed case reports/li/ulpQualifications and Experience:/pulliIn depth understanding of clinical research and pharmacovigilance operations and regulations-in particular an excellent knowledge of ICH GCP, GVP as well as FDA, EU and ROW regulations/lili5 + years of experience in clinical research and/or pharmacovigilance, including compliance/liliTeam player with excellent interpersonal skills/liliStrong attention to detail and excellent communication skills, both written and oral./liliExcellent knowledge of SOPs and auditing/compliance background preferred/liliEducation:/liliBachelors Degree required. Masters Degree preferred./li/ul/div

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