OverviewPharmacovigilance Specialist is responsible for operational delivery of assigned tasks at the project level. The Pharmacovigilance Specialist can act as the Primary or Secondary Project Responsible for the project assigned. The Pharmacovigilance Specialist communicates with the Pharmacovigilance Team Leader/Pharmacovigilance Manager about potential risks related to operational delivery, quality, client relationships and company reputation, as well as ad hoc project tasks and project requirements. The Pharmacovigilance Specialist may be engaged in the company’s procedures review and update.ResponsibilitiesSafety case reports workflow management.Safety case reports triage.Source documentation review, management and filing.Safety case reports data processing; SDB data entry, narrative writing, case assessment of seriousness, medical review with causality and expectedness assessment and reporting requirement assessment.Performing follow-up activities and query management.Quality Control steps of data entry and case processing.Safety case reports reconciliation.Line listings preparation.QualificationsAt least Bachelor’s Degree in life sciences field.Minimum 1 year of experience in safety and pharmacovigilance in pharmaceutical/CRO industry or newly graduated.Strong in verbal and written English and Italian.Located in Italy.Seniority levelEntry levelEmployment typeFull-timeIndustriesPharmaceutical Manufacturing
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