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Data officers
4 weeks ago
Product Life Group is looking for Data Officers (Pharmacovigilance) to join our dynamic team to contribute to the activities performed in the Hub.You will be required to work Easter USA Time Zone (6.30pm to 2.30 am IST)Responsibilities:To perform local safety case receipt, processing and data entry, quality control (QC) tracking and ICSR follow up of all safety information received for PLG clients, in accordance with agreed timelines, as requiredManagement of the generic or client specific email boxes as appropriate.Registration, triage, assignment and coordination for the processing of vigilance casesFollow-up requests with local reportersResponding to queries from client and reportersTo carry out periodic reconciliations aimed at confirming the proper handling of all vigilance reports for PLG ClientsSupport/Contribute to local pharmacovigilance (PV) activities performed by the Local safety/PV department as neededTo participate in audits / inspections and resulting action planEducation and Experience:Bachelor’s or Master’s degrees (according to the country and the experience) in Medicine, Pharmacy, nursing, or science related field, or equivalent experience2+ years’ experience in pharmacovigilance working for service providers performing data entry and QC of casesPrevious experience working to deadlines.Client communicationsKnowledge of US and EU PV regulationsPharmaceutical background – strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety.Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessmentSkills:Excellent organizational and interpersonal skillsAbility to work well within a teamExcellent time management skillsAccountability and autonomy with assigned tasksProcess orientated with good attention to detailEffective communications skills both written and verbal to be able to explain complex concepts and address queries from the team.Flexibility and adaptability to handle a dynamic workloadWorks well under pressure and working to timelinesSafety database experience
