Local Person for Pharmacovigilance (LPPV) – PharmaLex – Hørsholm

Local Person for Pharmacovigilance (LPPV)Locations: Austria, Belgium, France, Germany, Ireland, Italy, Netherlands, Nordics, Portugal, Spain, Switzerland, United Kingdom, Turkey Your Job Set up and manage the local pharmacovigilance systemLocal Literature SearchLocal ICSR ManagementPV Intelligence ScreeningLocal PSMF MaintenanceSetting up local Organized Data CollectionLocal PVA ManagementLocal adaptation and submission of PSUR / RMPLocal signal detectionImplementation of additional Risk Minimization MeasuresReviewing materials relating to local post-authorization safetyIntegrated first Level Medical Information and PQC SupportParticipate in PV-relevant audits and inspectionsAttend regular meetings according to project meeting scheduleProvide monthly PV report on status of local PV system in the country/iesEnsure PV training of affiliate employees, service providers and Third PartiesAct as primary contact for PV for Competent Authority in the Territory, including 24/7 availability if legally required.Interface between the EU-QPPV / Global PV team at client and the local regulatory authorityClose cooperation with the global PV system of the client as well as related global and local departments and functionsIssue, review and maintain pharmacovigilance procedures (i.e. Standard Operating Procedures, Working Practices) related to the local tasks in connection with client proceduresClose cooperation with the respective Deputy and providing the Deputy with information on relevant current PV activitiesDeputy is assuming responsibility in case of planned or unplanned absence Your Profile University degree in Medicine, Pharmacy or Life ScienceSeveral years’ experience and profound knowledge in the field of pharmacovigilanceExpertise, experience and knowledge regarding relevant global and local legislative and non-legislative guidelines on pharmacovigilanceDetailed knowledge of related SOPs (global and local)Participation in all relevant courses of instruction such as internal trainings and applicable external coursesExperience in all operative tasks that are performed by the members of the pharmacovigilance departmentFamiliarity with industry principles of pharmacovigilanceAbility to organise operational procedures and mange different tasks at the same time (e.g. effective coordination of personnel resources for time-conflicting projects)Ability to adjust rapidly to new, unknown, challenging situationsAbility to analyse and solve problems and to develop possible solutionsAutonomous, concentrated and high-quality workAbility to work in a teamSense of responsibilityVery good command of English If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line. Agencies only by prior agreement for the specific job opportunity.

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