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Drug Safety Specialist - Jobs in Mississauga, ON

Job LocationMississauga, ON
EducationNot Mentioned
SalaryNot Disclosed
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeFull Time

Job Description

Job Description SummaryResponsible for all activities related to the Global Pharmacovigilance (GPV) Central Safety Unit (CSU) processing of Individual Case Safety Report (ICSR) information from all sources including post-marketing, clinical trials and published literature. ICSR Case Processing, including but not limited to case receipt and registration, triage, data entry, quality control, and report review/submissions.Our Pharmaceutical Diagnostics (PDX) business is the number one global supplier of contrast media and molecular imaging agents used to enhance medical imaging exams. Used throughout all major disease area diagnostic and treatment pathways, PDX products support three patients every second around the world.Job DescriptionEssential Responsibilities

  • Receive, register, triage and process adverse event and medical device reports from all sources including post-marketing, clinical trials and published literature
  • Perform initial assessment of seriousness, expectedness, causality, and reportability in accordance with GPV processes and global regulatory requirements and guidelines
  • Perform data entry and quality review of adverse event reports into the global safety database, including accurate coding of MedDRA terms and preparation of case narratives
  • Identify missing or discrepant information and perform active case follow-up via verbal or written contact
  • Prepare expedited reports for submission to regulatory authorities and ethics committees
  • Serve as pharmacovigilance liaison and resource to internal and external groups (e.g., regulatory affairs, medical affairs, clinical development teams, CROs, etc.) on issues related to pharmacovigilance
  • Interface with quality assurance on product quality issues
    • Perform reconciliations between clinical, quality and PV databases
  • Support safety physicians in handling issues related to both clinical and post-marketing safety, as needed
  • Support preparation and submission of aggregate reports including PSURs, DSURs, and US Periodic Reports, as needed
  • Serve as pharmacovigilance resource during inspections and audits
Qualifications/Requirements
  • BS (Life Sciences Background) or equivalent with minimum of 3 years of pharmaceutical/biotechnology PV case processing experience, including clinical trial and postmarketing experience. Global experience preferred.
  • Proficient in all aspects of case processing, including case assessment (seriousness, expectedness, reportability), narrative writing, MedDRA coding, quality review and follow-up
  • Proficient in data entry and electronic reporting in global drug safety databases
  • Strong working knowledge of US/EU/AP/LA regulations and ICH guidelines
  • Understanding of Microsoft office applications, specifically Excel and Word
Desired Characteristics
  • Healthcare professional (Nurse or Pharmacist) with clinical experience preferred
  • Experience with Argus preferred
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership –always with unyielding integrity.Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.#LI-MA4Additional InformationRelocation Assistance Provided: NoQuick Apply
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