Pharmacovigilence Manager - Poland (Remote)

Posted 2024-11-22

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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

🗣️ Languages: Polish, English

⏳ Experience: Several years’ experience and profound knowledge in the field of pharmacovigilance

🪄 Skills: LeadershipProject ManagementData AnalysisProject CoordinationCross-functional Team LeadershipOperations ManagementData analysisCommunication SkillsAnalytical SkillsCollaborationProblem SolvingAttention to detailOrganizational skillsTime ManagementWritten communicationMultitasking

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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