pomorskie / Gdańsk
PV Quality Management & Trainings Specialist
2025-11-03
Twój rozwój. Nasza wspólna misja.Zdrowe jutro zaczyna się od ludzi, którzy tworzą Polpharmę – od ich wiedzy, zaangażowania i pasji. Wspólnie dbamy o zdrowie innych i tworzymy środowisko, w którym każdy może być sobą. Rozwijamy się w zgodzie z własnymi ambicjami, niezależnie od obszaru, w jakim działamy. Razem z nami możesz realnie wpływać na zdrowie i dobrostan innych.
Szukamy osoby na stanowisko:
PV Quality Management & Trainings Specialist
Miejsce pracy: Gdańsk
As a PV Quality Management & Trainings Specialist, you will be responsible for supporting the Pharmacovigilance (PV) and Product Safety Unit with a focus on quality management, training, and compliance. Your role will involve ensuring the alignment of PV processes with regulatory requirements, providing operational and scientific support, and driving the development and implementation of training strategies.
Your responsibilities:
- Training Management - Conducting PV trainings across the organization and for business partners; Developing, updating, and archiving training materials in compliance with internal and external regulations;
- Measuring the effectiveness of training programs and ensuring their alignment with organizational goals.
- Pharmacovigilance Quality Management - Ensuring PV processes comply with EU and international regulatory requirements; Supporting the operational management of the PV quality system, including policies, procedures, and tools; Performing quality control activities and implementing clear guidelines, instructions, and objectives within PV processes.
- Risk Analysis and Audit Support - Conducting risk analysis within the PV quality system and proposing audit strategies based on findings; Supporting internal and external audits in the PV area.
- Data Analysis and Reporting - Providing scientific analysis of pharmacovigilance data and expert medical knowledge to support healthcare professionals and patients; Ensuring accurate and timely reporting of safety-related information to stakeholders.
- Process Improvement and Digitization - Supporting process improvements and digitization initiatives within the PV area; Collaborating with cross-functional teams to enhance operational efficiency.
- Stakeholder Collaboration - Acting as a liaison between internal departments and external partners to ensure effective communication and alignment on PV-related matters; Promoting the safe and effective use of medicinal products by ensuring timely delivery of safety information to relevant stakeholders.
- Regulatory Compliance and Documentation - Ensuring the proper documentation of PV processes in compliance with applicable laws guidelines, and organizational policies; Supporting the purchase and management of quality standards, training documentation, and systems that support training management
Our requirements:
- Higher education (preferred in medicine, pharmacy, biotechnology, or a related field)
- Minimum 2-3 years of experience in a similar role within the pharmaceutical industry, preferably in pharmacovigilance, medical affairs, clinical trials, or R&D. Experience in conducting PV training and quality management is an advantage.
- Proficiency in MS Office and familiarity with tools supporting quality and training management
- Knowledge of pharmacovigilance quality management systems and EU/international PV regulations.
- Strong analytical and problem-solving skills.
- Excellent communication, interpersonal, and negotiation skills.
- Ability to work independently, make decisions, and take responsibility for outcomes.
- Proficiency in English (written and spoken).
- Auditor certification or experience conducting audits in the PV area.
We offer:
- Employment contract
- Private healthcare
- Life insurance
- Multisport card
- Special occasion bonus
- Christmas packages for children
- One extra day off
- Retirement plan