Associate Director, Pharmacovigilance Scientist

Location
Lake Forest, IL, United States
Posted
Aug 20, 2020
Ref
R0001910
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
Working at Horizon is more than a job - it's personal. For us, success is measured by the numbers that matter most - the number of lives we touch, the number we change and those we work tirelessly to help save. We're a team of agile, out-of-the-box thinkers who are inspired to do more because we know we're a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help others live up to theirs.

The Position

The Associate Director, Pharmacovigilance Scientist is responsible for the ongoing monitoring and assessment of the safety profile for the company's products.

Responsibilities:
  • Oversees the clinical and scientific content of periodic safety reports (PADER, PBRER, DSUR)
  • Contributes to the development and execution of qualitative and quantitative safety surveillance strategies for the company's development and marketed products
  • Identifies, validates, prioritizes, and performs assessment on safety signals
  • Manages development and execution of risk management plans
  • Contributes to safety-related justification documents to support the company's position regarding labeling (CCSI, local product label, investigator's brochure)
  • Contributes to ad hoc safety analyses in response to health authority, DSMB, and Ethics Committee/IRB queries
  • Contributes to the safety sections of NDA/MAA regulatory submissions documents
  • Reviews and contributes to study protocols, clinical study reports, investigator's brochure, informed consent forms, and other related clinical documents
  • Participates in continuous improvement of Horizon's processes and SOPs with regard to PV
  • Participates in cross-functional teams as a PV representative


Qualifications and Skills Required:
  • Bachelor's degree or equivalent (health professional degree preferred)
  • 7+ years of pharmaceutical or biotechnology experience of which 5+ years in a pharmacovigilance setting
  • Previous experience with safety databases (Argus, ARISg, or equivalent)
  • In-depth understanding of safety regulations for both marketed and investigational products, and general knowledge of regional and global authority requirements, including ICH, and other applicable requirements relating to patient safety and assessment of benefit-risk
  • Proficient in Microsoft Office
  • Professional demeanor
  • Self-starter attitude


Horizon Core Values & Competencies:

Growth
  • Manages Ambiguity
  • Strategic Mindset
  • Demonstrates Self-awareness
  • Cultivates Innovation
  • Develops Talent


Accountability
  • Drives Results
  • Ensures Accountability
  • Decision Quality


Transparency
  • Courage
  • Collaboration
  • Instills Trust


Horizon Therapeutics plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.