PV Quality Management

6 dni temu

Gdańsk Starogard Gdański, Polska Polpharma Pełny etat 40 000 zł - 80 000 zł rocznie

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

We offer:

  • Stable employment in a modern and dynamically-developing pharmaceutical company operating in international markets
  • Contract of employment
  • Hybrid system of work
  • Employee relocation package
  • Basic salary + bonuses
  • Private medical care
  • Subsidy for meals (350 PLN net)
  • Multisport card
  • Possibility to join group life insurance
  • Employee Pension Program
  • Points in the Motivizer cafeteria

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.

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