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Pharmacovigilance (case processing) specialist / italy

Roma
Delta PV
Pubblicato il 11 settembre
Descrizione

Job descriptionPosition OverviewPharmacovigilance Specialist is responsible for operational delivery for assigned tasks on the project level. Pharmacovigilance Specialist can act as the Primary or Secondary Project Responsible for the project assigned. Pharmacovigilance Specialists is communicating to Pharmacovigilance Team Leader/ Pharmacovigilance Manager about potential risk related to operational delivery, quality, client relationship and company reputation, as well as ad hoc project tasks and project requirements. Pharmacovigilance Specialist can be engaged in 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 managementQuality Control step of data entry and case processing.Safety case reports reconciliation.Line listings preparation.QualificationsAt least Bachelor’s Degree in life sciences fieldMinimum 1 year of experience in safety and pharmacovigilance in pharmaceutical / CRO industry or newly graduatedStrong in verbal and written English and ItalianMS Office expertiseLocated in Italy

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