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Safety Data Coordinator, Global Patient Safety

Employer
Novartis Gene Therapies
Location
Bannockburn, IL, US
Start date
May 31, 2019

View more

Discipline
Administration, Clinical, Clinical Project Management
Required Education
Masters Degree/MBA
Position Type
Full time
Hotbed
BioMidwest
Overview

Ready to join a team committed to moving gene therapies into the clinical and commercial settings 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 (ZOLGENSMA®). We are in the midst 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 Coordinator is a technical expert in Global Patient Safety (GPS) who manages the GPS mailbox for adverse events (AEs) intake and performs reconciliation with other departments. In this role, the individual will provide expertise to the Global Patient Safety (GPS) Operations Team in managing the AveXis day to day safety operations and cross-department collaboration. The Safety Data Coordinator will provide direct support to ensure information entered and retrieved from the AGSS is consistent, accurate and complete.

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

  • Receipt, triage and recording of all AE related communications that come into the GPS mailbox.
  • Archiving of all communications received to a shared safety repository.
  • Reconciliation of AEs, management and archiving of reconciliation documents.
  • Request and receipt of report AE listings from case processing vendors. Reviews and investigates AE listings for accuracy within allotted timeframes.
  • Queries vendors and other departments regarding discrepancies noted during the reconciliation.
  • Perform Source Data Verification (SDV) and archiving of SDV documents.
  • Assists in CAPA or Non-conformance investigations (as required).
  • Work cross-functionally with vendor, Clinical Operations Team and Safety Operations team.
  • Contribute to testing of new system configurations and AE report design.
  • Work with the AveXis' PV vendors for the pulling of Key Performance Indicators (KPIs).
  • Serve as resource for inspections and audits, including scribing, pulling requests and supporting the backroom.


Qualifications

  • 3-5 years' experience working within the Drug Safety/ Pharmacovigilance field.
  • Experience with Argus Safety database.
  • Experience with managing Safety mailbox and database hosting vendor.
  • Strong knowledge of applicable rules and regulations for the Global Pharmacovigilance.
  • 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.
  • Multi-tasking skills applied in different and complex assignments and ability to work effectively under pressure and under strict timelines.
  • Ability to communicate effectively both across global teams and with external partners.
  • Proficient MS Office skills.
  • Open to suggestions and feedback on continuous improvements.
  • Highly resilient, tenacious and resourceful.
  • 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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