Jazz Pharmaceuticals

  • Medical Safety Physician

    Job Locations US-CA-Palo Alto
    Posted Date 9 months ago(9/7/2017 1:19 PM)
    Job ID
    2017-1057
    # of Openings
    1
    Category
    Research & Development
  • 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

    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

    As a member of the Pharmacovigilance & Risk Management Team, the Director, Medical Safety Physician will be responsible for monitoring and maintaining the safety and risk profiles of investigational and marketed products.  This position is the Safety Management Team Lead accountable for ensuring that regular safety surveillance is performed according to internal procedures in compliance with regulatory requirements.  This is an individual contributor leadership position which requires excellent communication to influence and have a meaningful impact on matrix teams. Additional responsibilities may include supporting the medical review team with review of individual case safety reports and aggregate safety reports.

    Essential Functions & Key Responsibilities

    • Owns the strategy and execution of developing and maintaining product benefit and risk profiles
    • Conducts ongoing safety surveillance activities and risk analysis for investigational and marketed products
    • Performs critical and strategic review of safety data in support of ad hoc safety data review
    • Accountable for the identification, assessment and communication of potential safety signals
    • Contributes to the development and review of aggregate safety data and reports
    • Applies in-depth knowledge of company, external environment and industry best practices to analyze and solve issues
    • Provides appropriate medical interpretation and consistency to adverse event case assessment as requested
    • Contributes as a subject matter expert to departmental process improvement initiatives
    • Maintains knowledge of global regulatory authority regulations (especially FDA and EMEA) and apply appropriately to all activities
    • Participates in due diligence activities as appropriate.
    • Participates in departmental activities to ensure internal audit and regulatory inspection readiness
    • Contributes to the training, continuing education and development of department staff as requested by leadership
    • May perform medical review of individual case safety reports (clinical and spontaneous), including coding, seriousness, expectedness and Company causality assessment as requested

    Required Knowledge, Skills, and Abilities 

    • At least 8+years of experience post-residency, with at least 2 years of clinical experience and 5 years of experience in pharmacovigilance at a pharmaceutical/biotechnology company.
    • Knowledge and understanding of national and international regulatory guidelines and drug safety practices is required
    • Knowledge of medical aspects of drug safety in pre- and post-marketing safety practice is required
    • Exposure to working relationship with the FDA and other regulatory authorities is preferred
    • Knowledge of individual adverse event case report processing, triage and medical review is preferred
    • Experience with safety databases (Argus preferred) and safety coding dictionaries (MedDRA, WHODRUG) is preferred
    • Excellent oral and written communication skills
    • Excellent teamwork and interpersonal skills are required
    • Effective collaborator 

    Required/Preferred Education and Licenses 

    • M.D. degree required
    • Board certification in a specialty appropriate to the products of Jazz Pharmaceuticals preferred

    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.
    • Frequent computer use at workstation.
    • May move from one work location to another occasionally.
    • Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
    • Occasional public contact requiring appropriate business apparel.

    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.

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