Luminary Group is currently partnered with one of the leading Life Sciences companies in the world, specializing in providing services to the pharma, biotech, and MedTech industries.
As part of their ongoing success, our client is looking for a Local Person for Pharmacovigilance (LPPV) in Poland. This remote role will focus on the establishment and maintenance of the marketing authorisation holder’s local pharmacovigilance system, and will involve managing key operations such as local literature searches, ICSR management, signal detection, and overseeing local PV activities.
The ideal candidate will bring expertise in pharmacovigilance, a background in medicine, pharmacy, or life sciences, and proven experience with local pharmacovigilance tasks. This role offers flexibility in how you manage your schedule.
Local Person for Pharmacovigilance (LPPV)
- This is a remote job for someone who is already based in Poland and has proven experience with local pharmacovigilance activities
Your Job
Act 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 authoritySet 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 PartiesRequirements
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 responsibilityPolish language are a must. Very good command of English