Pharmacovigilance Specialist

Regulatory Affairs/Clinical Affairs Allegan, Michigan


Descripción

Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold.  Help us do it.

The Pharmacovigilance Specialist assists with monitoring the safety, efficacy, quality and compliance of Perrigo marketed products and clinical trial study drugs globally.

Key Responsibilities:

  • Receives and evaluates adverse drug experience and/or product complaints on all Perrigo products; performs initial and follow up triage (initial medical review) to identify adverse events and quality issues; determine event seriousness and prioritize case processing. Ensures source documents are maintained for each case. Manages follow up with consumers and healthcare professionals for the purpose of completing case documentation.
  • Ensures data accuracy, prepares accurate and complete case narratives; codes adverse event terms in MedDRA, determines expectedness of events according to local and global labels; seeks follow up and medical confirmation per process; refers for quality evaluation as appropriate, ensures regulatory reports are accurate and completed and submitted on time; ensures accurate documentation of all PV activity.
  • Reviews scientific and medical literature for individual case safety reports and safety-related findings.
  • Participates in aggregate data review activities; signal detection activities. Brings suspected safety concerns to management attention.
  • Prepares quarterly and annual safety reports for submission to FDA.
  • Performs analysis of aggregate date, reports out to team and provides QA feedback to case processing.
  • Partners with: 
    • License partners for safety data exchange agreements
    • Global sites PhV activities
    • Quality engineers on quality related investigations of adverse events
    • Regulatory Affairs for safety and labeling
Requirements:
  • Bachelor’s Degree in the medical field or life sciences, with Nursing or Pharmacy degree preferred.
  • A minimum of 2 years of related experience required.
  • Previous pharmacovigilance experience preferred.
  • Excellent communication skills, including strong verbal and interpersonal skills.
  • Excellent writing skills, detail-oriented; proven ability to write accurate and complete reports.
  • Strong decision making and organizational skills.
  • Strong problem solving skills, logical approach based on sound clinical and regulatory judgment.
  • Understanding of the importance of and compliance with procedural documents and regulations.
  • Strong research skills.
  • Ability to work under pressure with minimal supervision and maintain strictest confidentiality.
  • Ability to multi-task in fast paced environment.
  • Ability to work as part of a global, diverse team.
  • Willingness to engage in continuous improvement culture.
  • Computer literacy, including Microsoft Office and computer applications used for collecting and processing adverse events and product complaints.
  • Proven ability to read, understand, and apply U.S. and international law and regulatory guidance documents to job function.
  • Previous experience interacting with the public and the ability to handle sensitive and stressful situations appropriately.
  • In depth understanding of pathophysiology and the disease process.
  • Extensive knowledge of pharmaceutical products and their therapeutic uses.
  • Experience with medical coding or adverse event reporting, and working knowledge of FDA/EU/International regulations governing Adverse Event collection and reporting preferred.