Local Pharmacovigilance Manager

по договоренности
Москва
Опыт работы не важен

Job Responsibilities:

  • Responsible for local Pharmacovigilance System (EMR)
  • To ensure all local affiliate responsibilities are fulfilled as documented globally and in the PSMF
  • Intake, if applicable translate, and forward Adverse Events regarding pharmaceuticals and medical devices for processing within the Global Pharmacovigilance and Risk Management (GPRM) team, ensuring all cases are processed in a timely manner
  • Perform/manage reconciliation of Adverse Events for EMR
  • Prepare and manage local SOPs and written procedures according to local legislations and in line with Pharmacovigilance global SOPs
  • Ensure that local pharmacovigilance system is managed with local SOPs
  • Preparation and updating of SDEAs
  • Acting as the local Pharmacovigilance (PV) contact person for local health authorities and for the EU QPPV, as required
  • Support compilation of aggregate reports by providing requested EMR specific data
  • Participate in global PV training activities
  • Manage PV training for local affiliate employees incl. sales representatives as applicable
  • Support labeling update activities
  • Support Direct Healthcare Professional Communication and other risk minimisation measures, if applicable
  • Perform/organize local literature search (journals not listed in EMBASE); maintain, check and update list, documentation of local literature search
  • Keep senior managers updated of changes in local responsible persons
  • Keep local PV SOP updated on a regular basis
  • Act as local contact point for audit and inspections and related processes, including the preparation and maintenance of Inspection Binder
  • Support review of local agreements and compliance
  • To ensure appropriate archiving of relevant documentation and correspondence
  • To represent GPRM and the company in an ethical and positive manner
  • Work independently and responsibly in occasional work from home environment
    • Work Environment:

    • Competitive salary
    • Voluntary medical insurance
    • Life insurance
    • Mobile communication
    • Annual bonus
      • Requirements:

      • Minimum 2-4 years of working experience in pharmaceutical industry
      • Minimum 2-4 years of experience performing the functions of pharmacovigilance or materiovigilance, including review and reporting of adverse events, communication with Health Authorities/notified bodies
      • Degree in Medical Science strongly preferred or Pharmacist, Life Sciences degree
      • Knowledge of EMR laws and guidelines related to medicinal products and medical devices
      • Good spoken and written English knowledge, including medical terminology
      • Basic computer literacy, including Excel and PowerPoint
      • Analytical thinking and problem-solving skills
      • Excellent interpersonal and presentation skills
      • Strong patient orientation
        • Тип занятости:

          Полная занятость, полный рабочий день, у работодателя

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