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    ER

    Ergomed

    CRO (Contract Research Organization)

    Senior PV Associate

    Sofia, BulgariaRemoteFull-timePosted 1w ago
    All Ergomed jobs

    Job description

    • Providing support to other activities undertaken by the project team on behalf of the client and the company
    • Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to):
      • Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines
      • Performing ICSR follow up
      • SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)
      • Reconciliation (clinical, partners)
      • Personal data protection
      • Product Quality Complaint handling and interaction with Quality Assurance
      • Medical Information interaction
      • MedDRA and WHO coding
      • Database Outputs and Reports (including data for monthly reporting to clients)
      • Workflow & resource management
    • Support of PV processes related to the ICSR management within PrimeVigilance and also to clients
    • More senior colleague may perform tasks assigned as per SOP to more junior position
    • Performing activities in the scope of ICSR management unit within agreed extent and timeframe
    • Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager.
    • Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance
    • Minimum 1 year of work experience in pharmacovigilance
    • Organization skills, including attention to detail and multitasking
    • Management skills, including time and issue management
    • English - advanced (spoken, written)
    • Advanced literacy (MS Office)

    Why PrimeVigilance?

    We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

    To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.

    We offer:

    • Training and career development opportunities internally
    • Strong emphasis on personal and professional growth
    • Friendly, supportive working environment
    • Opportunity to work with colleagues based all over the world, with English as the company language

    Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!

    • Quality
    • Integrity & Trust
    • Drive & Passion
    • Agility & Responsiveness
    • Belonging
    • Collaborative Partnerships

    We look forward to welcoming your application.

    Job details are sourced from the employer's original posting.

    Open job posting
    ER

    About the company

    Ergomed

    Ergomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease. Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia Our company allows for employee visibility (you have a voice!) creative contribution and realistic career development. We have nourished a true international culture here at Ergomed. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. Come and join us in this exciting journey to make a positive impact in patient’s lives.

    View all Ergomed jobs
    Industry
    CRO (Contract Research Organization)
    Founded
    1997
    Open roles
    122

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