ApplyPharmacovigilence Manager - Poland (Remote)
Posted about 2 months agoViewed
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💎 Seniority level: Manager, Several years’ experience and profound knowledge in the field of pharmacovigilance
📍 Location: Poland
🔍 Industry: Life Sciences, pharma, biotech, and MedTech industries
🏢 Company: Luminary Group👥 1-10AdvertisingConsultingMarketingProfessional Services
🗣️ Languages: Polish, English
⏳ Experience: Several years’ experience and profound knowledge in the field of pharmacovigilance
🪄 Skills: LeadershipProject ManagementData AnalysisProject CoordinationCross-functional Team LeadershipOperations ManagementCommunication SkillsAnalytical SkillsCollaborationProblem SolvingAttention to detailOrganizational skillsTime ManagementWritten communicationMultitaskingTeamworkTraining
Requirements:
- University degree in Medicine, Pharmacy, or Life Science.
- Several years’ experience in pharmacovigilance.
- Knowledge of global and local pharmacovigilance guidelines and SOPs.
- Ability to organize operational procedures and manage multiple tasks.
- Polish language proficiency is a must; very good command of English.
Responsibilities:
- 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 and local regulatory authority.
- Set up and manage the local pharmacovigilance system.
- Conduct local literature search, ICSR management, and signal detection.
- Maintain local PSMF and organize data collection.
- Participate in audits and provide monthly PV reports.
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