Safety Scientist, Global Patient Safety

Employer
AveXis Inc.
Location
Bannockburn, IL, US
Posted
Sep 07, 2018
Ref
2018-1304
Hotbed
BioMidwest
Required Education
Masters Degree/MBA
Position Type
Full time
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. 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 Scientist (SS) reports to the Director, Global Patient Safety. The SS is responsible for ensuring high quality of aggregate report production, Safety Management Team meeting coordination, safety signal detection activities, and safety support for clinical development and product registration activities. The SS will work closely with Director and other GPS team members for safety surveillance, risk management, and risk communication for assigned products across product life cycle.

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

  • Collaborates with the SMO to ensure that all information is available to allow for informed medical review and benefit-risk assessment.
  • Contribute in the review of all safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process as well as post-marketing for assigned AveXis products.
  • Creates, coordinates, prepares and completes aggregate reports (e.g. PBRER, DSUR, PADER, as well as ad hoc queries or reports) for submission to regulatory agencies around the world.
  • Responsible for conducting Signal detection activities, meetings, documentation.
  • Conduct cross-functional Safety Management Team for assigned products.
  • Perform aggregate safety data tabulation and listing compilation.
  • Collaborate with clinical team, vendor and CRO safety physicians, medical monitors, toxicology group, and other functional groups in identification, analysis, and reporting of possible safety signals.
  • Contribute to development & maintenance of product safety profile.
  • Track events of special interest and assist in development & maintenance of standardized queries for events of special interest.
  • Contribute in responses to regulatory, EC/IRBs and Investigators or ad hoc inquiries regarding safety issues.
  • Develop and maintain strong relationships with key stakeholders including clinical development, medical affairs, regulatory affairs. Licensing and marketing organization to better understand and fully support business objective.


Qualifications

  • Relevant life sciences degree (e.g. PharmD, RN, MPH) with 3-5 years of professional experience
  • Min 5 years' experience in the pharmaceutical industry, predominately in Pharmacovigilance, having worked on both development and marketed products.
  • Clinical development and/or drug safety experience with biologics, gene therapy products desirable.
  • Credible knowledge of global regulations governing Pharmacovigilance for products in clinical development and post-marketing.
  • Strong written and verbal communication skills
  • 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
  • High attention to details
  • 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.