• Safety Data Analyst, Global Patient Safety

    Job Locations US-IL-Bannockburn
    Posted Date 4 days ago(6/14/2018 3:45 PM)
    Job ID
    2018-1301
    # of Openings
    1
    Category
    Global Patient Safety
  • Overview

    Ready to join a team committed to moving gene therapies into the clinical setting for patients and families devastated by rare neurological genetic diseases?  AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101.  We are at the beginning of an incredible journey, and are looking for passionate individuals to join us on this important mission.

     

    AveXis, Inc., a Novartis Company is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene.

     

    The Safety Data Analyst (SDA) is a technical expert in Global Patient Safety for data management, reports and queries. In this role, the SDA will provide technical expertise to the Global Patient Safety (GPS) Operations Team in managing the AveXis Global Safety System (AGSS) functionality. The SDA will support the Argus Safety system, oversee the hosting vendor and ensure that requests for system issues, enhancements and other system changes are resolved in a timely manner.

     

     

    This individual should be a self-starter with excellent pharmacovigilance knowledge and project management capabilities in pharmacovigilance who is seeking to be part of an innovative and fast-paced team to support the company’s drug development activities.

    Responsibilities

    • Own the complete lifecycle (concept through implementation/maintenance) of compliant, effective and efficient safety information management solutions for AveXis Global Patient Safety (GPS).
    • Provide direct technical /data management support to ensure information entered and retrieved from the AGSS is consistent, accurate and complete.
    • Accountable for the day-to-day oversight of the hosting vendor and managing SLAs (service level agreements) to ensure that outstanding tickets are resolved in a timely manner.
    • Lead GPS and cross-functional teams to implement new and updated business intelligence and systems solutions with global patient safety impact.
    • Serve as database administrator and completes tasks including safety database queries, database maintenance and validation activities
    • Manage and track the status of system change requests, enhancements and/or support efforts.
    • Support planning and implementation of safety system enhancements and upgrades in collaboration with the vendor.
    • Work with vendor, Clinical Operations Team and Safety Operations team to troubleshoot E2B reporting issues.
    • Maintains list of reporting algorithms and labelling decisions.
    • Contribute to testing of new system configurations and report design.
    • Gather and document user requirements for ad hoc and custom reports.
    • Perform ad hoc queries of the database and work with vendor as needed to develop validated queries/reports.
    • Maintain database user manual and safety system training materials.
    • Mentor PV staff on Safety System functionality.
    • Serve as resource person for inspections and audits, including delivering database queries.

    Qualifications

    • Bachelor’s degree in a Life Sciences discipline, Nursing or Pharmacy
    • 7-10 years’ experience working within the Drug Safety/ Pharmacovigilance domain including safety database management experience.
    • At least 3 years of pharmacovigilance systems experience.
    • Extensive experience with Argus Safety database including experience with creating advanced conditions and generating reports and listings in Argus.
    • Experience with managing database hosting vendor.
    • Strong knowledge of rules and regulations applicable to the Global Safety industry.
    • Attention to detail, results-oriented and persistent with excellent organizational skills.
    • Self-motivated and ability to work independently in a fast-paced environment, prioritize multiple tasks and ability to recognize time sensitivity.
    • Credible knowledge of global regulations governing Pharmacovigilance for products in clinical development and post-marketing.
    • Strong project management, organizational, planning, prioritizing and problem-solving skills
    • Effective multi-tasking skills, applied in different and complex assignments and ability to work effectively under pressure and under strict timelines
    • Ability to work both independently and collaboratively and use own initiative
    • Ability to communicate effectively both locally and globally, internally and externally
    • Proficient MS Office skills
    • Personality and attitude
    • Approachable, flexible and self-motivated
    • Open to changes, suggestions and innovations, continuously on the look-out for work processes' improvements
    • Tolerance for ambiguity and ability to adapt quickly to a changing business environment
    • Highly resilient, tenacious and resourceful
    • Occasional travel (up to 40%) for conferences, meetings and professional development activities

    Non-Essential Functions: 

    • Strives to maintain a safe working environment through the prevention of accidents, the preservation of equipment, and the achievement of safe working practices.
    • Maintains a positive and professional demeanor toward all customers and coworkers.
    • Adheres to all policies and procedures of AveXis.
    • Performs other duties as assigned.

     

    The level of this position will be based on the final candidate’s qualifications.

     

    Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. 

     

    AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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