Senior Manager, Risk Management Scientist, Global Patient Safety

Employer
AveXis Inc.
Location
Bannockburn, IL, US
Posted
Sep 12, 2018
Ref
2018-2501
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
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. 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.

In this role, the Risk Management Scientist will lead, develop, coordinate and manage all aspects of RMPs/REMS related activities/commitments for assigned products. The Risk Management Scientist will work closely with Director, Medical Safety and other GPS team members for safety surveillance, risk management, and risk communication across product life cycle.

This individual should be a self-starter with demonstrated expertise in leading RMP/REMs programs and project management capabilities in pharmacovigilance/drug safety who is seeking to be part of an innovative and fast-paced team to support the company's drug development/post-marketing safety surveillance activities.

Responsibilities

  • Develop and manage Global Risk Management Plans (RMPs), Pharmacovigilance Plans and Risk Evaluation and Mitigation Strategies (REMS) programs for assigned products.
  • Contribute and provide risk management scientific expertise for safety documents/reports (PBRER, DSUR, PSUR, PADER) and regulatory responses.
  • Lead and manage global and regional Risk Management commitments, actions, project and regulatory timelines.
  • Coordinate Risk Management activities with contributions from cross functional teams, internal and external partners, service providers.
  • Develop standard procedures and templates relevant for risk management activities including RMPs, REMS.
  • Ensure all risk management/REMS documents are prepared according to regional regulatory requirements and facilitate cross-functional review and sign-off.
  • Support GPS medical safety team on safety surveillance activities as needed.


Qualifications

  • Bachelor's degree in a Life Sciences discipline, Nursing or Pharmacy.
  • 5-7 years' experience working within the Drug Safety/ Pharmacovigilance domain including RMP/REMS management experience.
  • At least 3 years of hands-on RMP/REMS development/management experience.
  • 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 10%) for conferences, meetings and professional development activities.
  • 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.