Offer summary

Qualifications:

University degree in Medicine, Pharmacy, or Life Science., Several years of experience in pharmacovigilance with profound knowledge of relevant guidelines., Familiarity with industry principles and operational tasks in pharmacovigilance., Fluency in Polish and very good command of English..

Key responsabilities:

Act as the primary contact for pharmacovigilance with the Competent Authority in Poland.

Set up and manage the local pharmacovigilance system, including literature searches and ICSR management.

Provide monthly reports on the status of the local pharmacovigilance system and ensure training for affiliate employees.

Participate in audits, inspections, and regular project meetings to ensure compliance and operational efficiency.

Job description

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.

The ideal candidate will bring expertise in pharmacovigilance, a background in medicine, pharmacy, or life sciences, and proven experience with local pharmacovigilance tasks. This role offers flexibility in how you manage your schedule.

Local Person for Pharmacovigilance (LPPV)

* This is a remote job for someone who is already based in Poland and has proven experience with local pharmacovigilance activities*

Your Job

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

Requirements

Your Profile

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 mange 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