Pharmacovigilence Manager - 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.

Requirements

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

Benefits

• Remote work opportunity.
• Flexible schedule.