ProductLife Group is looking for a Local Safety Officer in Brazil to join our dynamic team to contribute to the activities performed in the Hub.ResponsibilitiesAct as a Local Safety Officer on behalf of PLG clients in a BrazilEnsure the continuity of service for the activities inherent to the vigilance responsibilities delegated to PLGResponsible for keeping up to date with local regulatory requirementsTo communicate with local authorities and PLG clients professionally and according to given timelinesCreation and/or Maintenance of local PSMF (as required)Support of local PV system, including creation of a local SOPs and agreements Review / update Safety Data Exchange Agreement (SDEA) / Pharmacovigilance Agreement (PVA) / Technical Agreement (TA) as requiredSupport/Contribute to local pharmacovigilance (PV) activities performed by the pharmacovigilance /Medical Information line of business in local countryLiaise with client, affiliate departments and other 3rd party vendorsTo comply with client and PLG policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectivesContribute/support to the production of client administrative documents, reports and tracking toolsTo participate in audits / inspections and resulting action planEnsure confidentiality and data protection rules are followed, as applicable Safety information and Medical Information management:To perform safety case receipt, processing, translation, quality control (QC) tracking and ICSR follow up of all safety information received for PLG clients in Brazil, in accordance with agreed timelines, as requiredPerform Local ICSR submissions to local regulatory authorities in Brazil according to local legislationTo carry out periodic reconciliations aimed at confirming the proper handling of all vigilance reports for PLG ClientsProvision or support of local medical information services (as required)Local literature and regulatory website monitoringMonitoring of Local literature/journal(s) for PLG's clients products in Brazil (as required)Perform QC and track activity and results from the literature monitoringAssist in selection and review of local journal list when requiredTo monitor local Braziln authority websites for changes in national legislation or safety information relevant for PLG clientsTracking of regulatory authority screening and providing results to relevant PLG clientsOther responsibilities (optional):Support/oversight of local studies and risk minimisation measures/ activity.To perform DSUR, PSUR and RMP translation and submission, as requiredProvision of training to PV stakeholders (sales rep, distributors, affiliate), as requiredEducation and ExperienceBachelor'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 pharmacovigilanceExcellent knowledge of local Brazil and international regulationsExperience in local PV case management, including receipt, translation, submission and follow up is essentialExperience in acting as a local contact person in Brazil is desirableExperience in local literature and regulatory website screening is desirablePrevious experience performing local pharmacovigilance activities in Brazil for a European company is desirableExperience of safety database/MedDRA is desirableSkillsExcellent organizational and interpersonal skillsAbility to work well within a teamExcellent time management skillsAccountability and autonomy with assigned tasksProcess orientated with good attention to detailGood understanding of MS Word, MS ExcelBrazilian Portuguese – Native speaker and/or fluent (written and verbal fluency)Excellent English language and grammar skills (written and verbal fluency)
