Patient Safety Specialist I

Top 3 “must haves”: A bachelor’s degree is required (preferably in a medical or science-related discipline); relevant experience may be substituted for the degree when appropriate (e.g., a Registered Nurse with clinical experience).A minimum of 2 years of progressively responsible and relevant pharmacovigilance experience, including MedDRA coding and adverse event identification, is required.Exceptional knowledge of medical and pharmacovigilance terminology is requiredPurposeResponsible for the receipt, processing, triage and quality assessment of all inbound safety information, including adverse events and technical complaints, for client US marketed products (drugs and devices) and investigational products. Also responsible for ensuring compliance with all internal and external (e.g. FDA) drug and device safety reporting requirements regarding the collection and maintenance of safety records.RelationshipsReports to Patient Safety Management.Daily internal interactions with personnel from Patient Safety , Medical Information, Field Sales, Customer Complaints Center, Suppliers and Patient Centric Customer Care.Daily external interactions with patients, caregivers, and health-care professionals.Essential FunctionsAbility to perform all responsibilities of more junior staff, including but not limited to: Processing of ad-verse events and associated technical complaints and analysis results related to marketed products into the local intake, complaint, and global safety databases, including but not limited to:Duplicate searchesProduct codingMedDRA codingNarrative generationLabeling assessment according to the current approved product labelReceive inbound and make outbound calls for adverse events and technical complaints including handling of refund of replacement requestsPerform data entry and review of adverse events and associated technical complaints and provide ongoing feedback regarding case quality to other case handlers to support their continued development and ensure excellent case qualityHandle incoming and outgoing follow-up correspondenceCollect and document information received during outbound follow-up callsPerform triage, case classification and case assignmentHandle escalated calls for adverse events and technical complaintsAssist with training of new hires; mentor new hiresPerform reconciliationsAssist with workload coordination/distributionPerform call monitoringSupport the identification of trends and implementation of corrective actions for issues identified during case reviewCoordinate configuration requests for the safety and complaint databasesServe as Subject Matter Expert during audits/inspections for case handlingBuild customer loyalty by providing high quality customer serviceProvide professional, accurate and timely responses to product information questions and other inquiries using currentapproved product labeling and call scriptsIdentify procedural deficiencies and opportunities for process improvements; make improvement recommendations tomanagement and support implementation of solutionsAssist with department related projectsQualificationsBachelor’s degree required (in medical or science-related discipline preferred); relevant experience may be substituted for degree when appropriate (e.g. Registered Nurse with clinical experience).A minimum of 2 years of progressively responsible, relevant pharmacovigilance experience (including MedDRA coding and adverse event identification) requiredA minimum of 2 years of Customer Service experience preferredExceptional knowledge of medical and pharmacovigilance terminology requiredKnowledge of client supported disease states preferred (e.g. diabetes, obesity, hemophilia, growth hormone disorders)Experience with audits/inspections preferredAnalytical thinking skills requiredProficiency in Windows, Microsoft Word, Excel and Outlook requiredExperience with a Call Center and Drug Safety database preferredStrong oral and written communication skills requiredAbility to work with sensitive or confidential information requiredStrong attention to detail requiredAbility to handle multiple priorities and demands in a fast-paced environment requiredStrong planning, organizational and time management skills requiredAbility to interact with various levels of the organization requiredAbility to form strong working relationships with stakeholders requiredBi-lingual (Spanish-English) a plus