Qppv Manager

Summary

Join Luminary Group and work remotely as a Local Person for Pharmacovigilance (LPPV) in Poland for a leading Life Sciences company. This role centers on establishing and maintaining the local pharmacovigilance system. Responsibilities include managing local literature searches, ICSR management, signal detection, and overseeing local PV activities. The ideal candidate will possess expertise in pharmacovigilance, a background in medicine, pharmacy, or life sciences, and proven experience with local pharmacovigilance tasks. This position offers schedule flexibility. The role requires fluency in Polish and English.

Requirements

• University degree in Medicine, Pharmacy or Life Science
• Several years’ experience and profound knowledge in the field of pharmacovigilance
• Expertise, experience and knowledge regarding relevant global and local legislative and non-legislative guidelines on pharmacovigilance
• Detailed knowledge of related SOPs (global and local)
• Participation in all relevant courses of instruction such as internal trainings and applicable external courses
• Experience in all operative tasks that are performed by the members of the pharmacovigilance department
• Familiarity with industry principles of pharmacovigilance
• Ability to organise operational procedures and manage different tasks at the same time (e.g. effective coordination of personnel resources for time-conflicting projects)
• Ability to adjust rapidly to new, unknown, challenging situations
• Ability to analyse and solve problems and to develop possible solutions
• Autonomous, concentrated and high-quality work
• Ability to work in a team
• Sense of responsibility
• Polish language are 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 at client and the local regulatory authority
• Set up and manage the local pharmacovigilance system
• Local Literature Search
• Local ICSR Management
• PV Intelligence Screening
• Local PSMF Maintenance
• Setting up local Organized Data Collection
• Local PVA Management
• Local adaptation and submission of PSUR / RMP
• Local signal detection
• Implementation of additional Risk Minimization Measures
• Reviewing materials relating to local post-authorization safety
• 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 status of local PV system in the country/ies
• Ensure PV training of affiliate employees, service providers and Third Parties

Benefits

• This is a remote job for someone who is already based in Poland and has proven experience with local pharmacovigilance activities
• Flexibility in how you manage your schedule