Case Specialist (Pharmacovigilance)
ProductLife Group · Philippines
Tailor my CV for this job — freeProductLife Group is looking for a Case Specialist (Pharmacovigilance) to join our dynamic team to contribute to the activities performed in the Hub:Its on a Mid Shift system for Philippines and completely Remote basis.
Responsibilities
Responsible for the Quality control of vigilance casesMedical evaluation of reportsData entry of vigilance cases in ad hoc databases or in other formats agreed with the clientFollow-up request of vigilance cases by phone/mailPre-analysis of complex cases prior to data entryMedical evaluation of files on:Coding (according to applicable dictionary)Causal relationship between the effects and the intake of suspect products (according to applicable method)The expected/listed or unlisted nature of the events/effects/incidentsThe seriousness of the events/effects/incidents and the caseIdentification of submission requirements for each caseValidation of certain documents produced by the Data Manager/ Vigilance Associate / documentalist (phone call forms, etc)Closing of vigilance filesIdentification of requirements and applicable changes to set up ICSR/MLM filtersAnalysis of inclusion / exclusion of EV/MHRA casesMedical information in support of the medical information divisionRelated to particular activities carried out in their Business unit for specific clientsEducation & ExperienceDoctor or pharmacist by trainingMinimum 4 years experience working for service providers performing QC of caseProfileDatabase experience preferredKnowledge of current regulationsProcess orientedRigorous and ability to work in a teamUse of Microsoft Office toolsAbility to multitaskFlexibilityExcellent communication skills in English