Local Person for Pharmacovigilance (LPPV) - Poland - Remote

Overview

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.

In Short

• 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.
• Manage local ICSR.
• Perform PV intelligence screening.
• Maintain local PSMF.
• Set up local organized data collection.
• Manage local PVA.
• Adapt and submit PSUR / RMP locally.
• Conduct local signal detection.
• Implement additional risk minimization measures.
• Review materials related to local post-authorization safety.
• Provide integrated first level medical information and PQC support.
• Participate in PV-relevant audits and inspections.
• Attend regular meetings according to project meeting schedule.
• Provide monthly PV report on the status of local PV system in the country/ies.
• Ensure PV training of affiliate employees, service providers, and third parties.

Requirements

• Proven experience with local pharmacovigilance activities.
• Background in medicine, pharmacy, or life sciences.
• Ability to manage schedule flexibly.

Benefits

• Remote work opportunity.
• Flexibility in managing your schedule.