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Senior Manager, Pharmacovigilance Scientist

Company: Horizon Pharma
Location: Deerfield
Posted on: June 8, 2021

Job Description:

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.

Position Summary:

The Senior Manager, Pharmacovigilance Scientist is responsible for managing and tracking of safety science deliverables to internal and external customers.

Responsibilities:

  • Manages and tracks the production of periodic safety reports (PADER, PBRER, DSUR) and the department's contribution to annual reports (NDA Annual Report and IND Annual Report)

  • Manages and tracks the safety surveillance strategies for the company's development and marketed products

  • Manages the identification, prioritization, and assessment of safety signals

  • Manages and tracks the production of risk management plans for the company's marketed products

  • Manages and tracks ad hoc safety analyses in response to health authority, DSMB, and Ethics Committee/IRB queries

  • Manages, tracks, and makes updates to safety management plans for company-sponsored studies

  • Assists with the development of safety sections of study protocols, clinical study reports, investigator brochures, and other related clinical documents

  • Manages and tracks other safety science deliverables to internal and external customers

  • Participates in cross-functional teams as a PV representative

Qualifications and Skills Required:

  • Bachelor's degree or equivalent (health professional degree preferred)

  • 5+ years of pharmaceutical or biotechnology experience of which 3+ years in a pharmacovigilance setting

  • Previous experience with safety databases (Argus, ARISg, or equivalent)

  • Knowledge and understanding of pharmacovigilance regulations for both marketed and investigational products

  • Proficient in Microsoft Office

  • Professional demeanor

  • Strong interpersonal skills.

  • Excellent written and verbal communication skills

The Person:

This role requires good judgment and strong initiative. You need to have the ability to effectively prioritise and manage a diversified workload, often to strict deadlines. You should have strong interpersonal skills, a professional approach with excellent written and verbal communication skills.

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.

Keywords: Horizon Pharma, Arlington Heights , Senior Manager, Pharmacovigilance Scientist, Other , Deerfield, Illinois

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