QPPV Manager Poland (Remote)

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Requirements:

• University degree in Medicine, Pharmacy, or Life Science.
• Several years of experience and profound knowledge in pharmacovigilance.
• Expertise in global and local legislative guidelines related to pharmacovigilance.
• Detailed knowledge of relevant SOPs (global and local).
• Participation in relevant training courses.
• Experience in operational tasks of the pharmacovigilance department.
• Ability to organize procedures and manage multiple tasks.
• Strong problem-solving and analytical skills.
• Ability to work autonomously and in a team.
• Fluent in Polish and very good English.

Responsibilities:

• Act as primary contact for PV for Competent Authority in the Territory.
• Interface between the EU-QPPV / Global PV team and local regulatory authority.
• Set up and manage the local pharmacovigilance system.
• Conduct local literature searches and manage local ICSR.
• Perform PV intelligence screening and maintain local PSMF.
• Oversee local data collection and adaptation/submission of PSUR/RMP.
• Conduct local signal detection and implement risk minimization measures.
• Review materials regarding local post-authorization safety.
• Provide first-level medical information and PQC support.
• Participate in PV audits/inspections and provide monthly PV reports.
• Ensure PV training for affiliate employees and third parties.