The Team Lead / Local Safety Specialist (LSS) will be responsible for managing local pharmacovigilance activities in Hungary, leading client projects, mentoring junior staff, and ensuring regulatory compliance. This role combines team leadership, client management, and hands-on PV responsibilities, including acting as the Local Safety Officer (LSO) for Hungary.

Key Responsibilities:

Team & Client Management

  • Lead and mentor junior PV team members to enhance quality and knowledge of case processing activities.
  • Act as LSO Coordinator and primary client contact for local safety projects across multiple countries.
  • Oversee setup, execution, and monitoring of small to complex local safety projects.
  • Review team performance and identify areas for improvement.
  • Serve as Subject Matter Expert (SME) for PV tasks and ensure team understanding.
  • Manage large client projects and maintain client relationships within the territory.
  • Monitor client KPIs and ensure expectations are met or exceeded.
  • Support resolution of NC/CAPA, identify root causes, and implement corrective actions.
  • Conduct Quality Control (QC) and Medical Review to ensure regulatory compliance.
  • Participate in audits and inspections as required.
  • Organise and lead team meetings.

Patient Safety & Risk Management

  • Act as Local Safety Officer (LSO) for PLG clients in Hungary.
  • Liaise with local regulatory authorities and ensure timely communication.
  • Notify authorities of LSO appointment and ensure service continuity.
  • Stay updated on local PV regulations and communicate changes to clients.
  • Maintain and update local Pharmacovigilance System Master File (PSMF).
  • Support creation and maintenance of local SOPs and agreements.
  • Review and update Safety Data Exchange Agreements (SDEA), Pharmacovigilance Agreements (PVA), and Technical Agreements (TA).
  • Collaborate with Medical Information and PV teams for local activities.
  • Ensure compliance with PLG and client policies and procedures.
  • Contribute to client documentation, reports, and tracking tools.
  • Ensure data protection and confidentiality standards are upheld.

Safety Information & Medical Information Management

  • Perform safety case receipt, processing, translation, QC, tracking, and ICSR follow-up for PLG clients.
  • Submit ICSRs to local authorities in accordance with Hungarian legislation.
  • Conduct periodic reconciliations of vigilance reports.
  • Provide or support local medical information services.
  • Monitor local literature and regulatory websites for safety updates.
  • Track and report findings from literature and authority screenings.

Qualifications & Experience:

  • Bachelor’s or Master’s degree in Medicine, Pharmacy, Nursing, Midwifery, or Life Sciences (as per local requirements).
  • Minimum 6 years’ experience in pharmacovigilance.
  • At least 2 years’ experience with service providers performing case data entry and QC.
  • Previous experience in line management and mentoring junior staff.
  • Proven client and project management experience.
  • Experience in local PV activities in Hungary is highly desirable.
  • Strong knowledge of EU PV regulations and safety database systems.
  • Familiarity with GCP, FDA, and other regulatory frameworks.

Skills & Competencies:

  • Native Hungarian speaker or fluent in Hungarian (written and verbal).
  • Fluent in English (written and verbal).
  • Proficient in MS Word and Excel.
  • Excellent organisational, interpersonal, and time management skills.
  • Strong attention to detail and process orientation.
  • Effective communication skills to explain complex concepts.
  • Ability to work under pressure and meet deadlines.
  • High level of accountability and autonomy.

Team Lead/Local Safety Specialist

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