Patient Safety Assistant

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Employer: Novartis Pharma Services Romania
Domain:
  • Pharmacy - Health
  • Job type: temporary
    Job level: 1 - 5 years of experience
    Location:
  • BUCHAREST
  • Updated at: 19.03.2019
    Short company description

    Novartis este unul dintre liderii din industria medicala la nivel global si un angajator important, cu peste 120.000 de angajati. Compania are sediul central in Basel, Elvetia si ofera solutii inovatoare pentru nevoile, in continua crestere, ale pacientilor din intreaga lume. Produsele companiei sunt disponibile in peste 180 de tari la nivel mondial.

    Requirements

    - Degree in Medicine/Pharmacy or related fields;
    - Fluent English (written and spoken);
    - PC skills (Excel, Word, PowerPoint);
    - Learning agility (especially for tools);
    - Experience on similar position in drug safety/ clinical research/regulatory affairs.

    Responsibilities

    - Prepares the specific submission documents to Health Authorities;
    - Prepares and everyday distributes the respective Patient Safety documents externally;
    - Archives all safety documentation as per respective policies, guidance and procedures;
    - Manages collection, processing, documentation, reporting and follow-up of all serious adverse events (SAE) reports for all Novartis products from clinical trials, post-marketing studies (PMS), registries, and all adverse events from commercial, sales and marketing programs and all Spontaneous Reports (SR);
    - Transcribes, translates and enters data of all Serious Adverse Events (from Clinical Trials, post-marketing studies (PMS), registries) and all adverse events (from commercial, sales and marketing programs and all Spontaneous Reports) from source documents onto safety systems (e.g. Argus Affiliate, etc.) accurately and consistently with emphasis on timeliness and quality;
    - Performs reconciliation with other departments (e.g. Medical Information, Quality Assurance and third party contractor, if applicable) for potential AEs resulting from medical inquiries and quality related complaints.