Covance

  • Drug Safety Associate

    Job Location(s) BG-Sofia | BG
    Job Number
    2018-19666
    Job Category
    Clinical Operations
    Position Type
    Full-Time
  • Job Overview

    Get ready to redefine what’s possible and discover your extraordinary potential at Covance. Here, you’ll have the opportunity to personally advance healthcare and make a difference in peoples’ lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.

     

    This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.

    We are currently seeking a Drug Safety Associate to join our expanding team in Sofia, Bulgaria.

     

    Essential Job Duties:

     

    • Manage the receipt and processing of all adverse event reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to:
      • entry of safety data onto adverse event database(s) and tracking systems
      • review of adverse events for completeness, accuracy and appropriateness for expedited reporting
      • write patient narratives
      • code adverse events accurately using MedDRA
      • determine expectedness/listedness against appropriate label
      • identifies clinically significant information missing from initial report and ensures its collection
      • ensure case receives appropriate medical review
      • prepare follow-up correspondence consulting the medical staff accordingly
      • ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines
      • reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines
    •  Maintain a strong understanding of Covance's safety database conventions or client specific database conventions, as appropriate.
    • Begin participating in signal detection and trend and pattem recognition activities, as appropriate.
    • Begin preparing timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events
    • Assist in the preparation of listings for Annual IND reports, Periodic Reports (PRs) and Periodic Safety Update Reports(PSURs).
    • Work with Data Management or client on reconciliation of safety databases.
    • Begin participating in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.
    • Support/train less experienced safety staff in all aspects of case-handling, adverse event reporting.
    • Maintains a comprehensive understanding of Covance Safety's Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance
    • Possess knowledge of other procedural documents, e.g., SOPs, etc. that impact Safety.
    • Ensure compliant safety reporting in accordance with US and international reporting regulations, SOPs and safety processing guidelines set forth by departmental management team and the client.
    • Build and maintain good PV &DSS relationships across functional units.
    • Demonstrate role-specific Competencies on a consistent basis.
    • Demonstrate company Values on a consistent basis.
    • Begin to develop a good knowledge of contract assumptions; identifying out of scope work.
    • Read and understand Safety Management Plans (SMPs), Reconciliation Plans, and other safety specific plans ensuring optimal efficiency.
    • Begin participating in Covance project teams and client meetings as appropriate.
    • Assist in the review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients.
    • Assist with the set-up of, and the provision of data to, Safety Committees/DSMBs.
    • Assist in the co-ordination of endpoint committees, as required.
    • Any other duties as assigned by management.

     

    Education / Qualifications

    Degree preferred to be in one or more of the following disciplines: Biological Sciences, Phannacy, Nursing, Life Sciences, and Chemistry.

     

    Experience

    Required:

    • Non-degree + 4-5 yrs relevant experience (or 2 yrs safety experience)*
    • Associates Degree + 3-4 yrs relevant experience (or 1-2 yrs safety experience)*
    • Associate degree RN + 2-3 yrs relevant experience (or 1-2 yrs safety experience)*
    • BS/BA + 1-2 yrs relevant experience**
    • MS/MA + 0 yr relevant experience**
    • PhannD + 0 yrs relevant experience**

    *Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatmy submissions.

    **Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance.

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