Local Person for Pharmacovigilance (LPPV) - Poland

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Requirements:

• University degree in Medicine, Pharmacy or Life Science.
• Several years’ experience and profound knowledge in pharmacovigilance.
• Expertise in relevant global and local legislative guidelines.
• Detailed knowledge of related SOPs (global and local).
• Experience in operative tasks performed by pharmacovigilance department members.
• Ability to manage multiple tasks and adapt to challenging situations.
• Strong analytical and problem-solving skills.
• Ability to work autonomously and in a team.
• Fluency in Polish is mandatory; 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 at client and the local regulatory authority.
• Set up and manage the local pharmacovigilance system.
• Conduct Local Literature Searches and Local ICSR Management.
• Carry out PV Intelligence Screening and maintain Local PSMF.
• Organize local data collection and manage Local PVA.
• Adapt and submit PSUR / RMP locally and perform local signal detection.
• Implement additional Risk Minimization Measures and review post-authorization safety materials.
• Provide first-level Medical Information and PQC Support.
• Participate in PV-relevant audits and inspections.
• Attend regular meetings and provide monthly PV reports.
• Ensure PV training of affiliate employees, service providers, and Third Parties.