Jazz Pharmaceuticals

  • Pharmacovigilance Records Analyst (12 Month Fixed Term Contract)

    Job Post Information* : Posted Date 4 weeks ago(7/26/2018 9:55 AM)
    ID
    2018-3700
    # of Openings
    1
    Min. Exp. (Yrs)
    2
    Category
    Research & Development
    Advertised Location : Location
    UK-Oxford
    Job Post Information* : External Company Name
    Jazz Pharmaceuticals
    Job Post Information* : External Company URL
    https://www.jazzpharma.com/
    Advertised Location : Address
    Spires House
    Advertised Location : Postal Code
    OX4 2RW
  • Overview

    Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.


    Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.


    We are looking for the best and brightest talent to join our team.  If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals. 

    Position Profile

    The Pharmacovigilance Records Analyst is responsible for facilitating and supporting the global review of departmental documents, ensuring the records are maintained in compliance with the Company’s SOPs and records management policies, as well as legal and regulatory requirements. 

    The position is project-specific and will be working with a designated global project team, following a structured project management plan, adhering to strict timelines.

    Essential Functions

    • Review and organize the PV departmental electronic and hard copy files and update various document storage repositories and databases as needed
    • Work closely with departmental SMEs to identify and classify a variety of document types
    • Track document assessment and disposition accurately and on a continuous basis
    • Requires the ability to work both independently and in collaboration with the global teams
    • Other duties as assigned

    Minimum Requirements

    • Knowledge of GxP regulations and GDPR awareness
    • Familiarity of GVP related documentation and good knowledge of good documentation practice
    • Exceptional attention to detail and aptitude in document review
    • Knowledge of organizing and maintaining records and databases
    • Proficiency in Microsoft Office (i.e. Outlook, Excel, Word, and PowerPoint)
    • Ability to demonstrate Jazz values and leadership competencies

    Required Knowledge, Skills, and Abilities

    • 2+ years’ experience working in a pharmacovigilance role, with exposure to both clinical and post-marketing safety data
    • Knowledge of PV quality assurance activities preferred
    • Ability to multi-task and shift priorities
    • Exceptional organizational skills
    • Ability to communicate effectively, both verbally and in writing
    • Works efficiently with little supervision

    Required/Preferred Education and Licenses

    • A-level or equivalent qualifications

    Description of Physical Demands

    • Occasional mobility within office environment.
    • Routinely sitting for extended periods of time.
    • Constantly operating a computer, printer, telephone and other similar office machinery.

    Description of Work Environment

    • Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
    • Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands (e.g. assisting with health authority inspections)
    • Occasional public contact requiring appropriate business apparel (e.g. assisting with health authority inspections)

    Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

    Jazz Pharmaceuticals is an Equal Opportunity Employer.

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