Pharmacovigilance Information Specialist GPIO

4 weeks ago


Dublin, Dublin City, Ireland Parexel Full time

Parexel is seeking a skilled Pharmacovigilance Information Specialist (PVIS) to join the Global Pharmacovigilance Information Office (GPIO) team in Dublin, Ireland. This role involves researching, reviewing, and maintaining information related to safety reporting requirements for clinical trials and post-market projects.

Responsibilities:

  • Research and maintain drug and device safety reporting regulatory intelligence
  • Review and update country safety requirements
  • Communicate with Regulatory Authorities, Ethics committees, and local safety contacts for safety regulatory updates
  • Update relevant databases, trackers, and logs as per SOPs
  • Respond to queries regarding safety reporting requirements
  • Collaborate with and assist the GPIO team in day-to-day activities
  • Participate in internal and external team meetings
  • Ensure work meets defined quality and compliance standards
  • Provide expertise on safety reporting requirements to PV Operations staff
  • Prepare for and respond to audits and inspections
  • Maintain up-to-date knowledge of regulations and SOPs
  • Perform other tasks as assigned

Skills:

  • Knowledge of expedited and periodic drug safety reports
  • Understanding of drug development process
  • Ability to interpret global safety regulations
  • Experience in reading and researching legislation and guidance documents
  • Strong presentation and communication skills
  • Analytical and problem-solving skills
  • Excellent interpersonal, organizational, and prioritization skills
  • Ability to work collaboratively in a team
  • Client-focused approach
  • Proficiency in computer applications and database management

Knowledge and Experience:

  • Experience in reporting safety reports to Regulatory Authorities, Ethics committees, or Investigators
  • Experience with clinical trial or post-market drug safety studies

Education:

  • Degree in Pharmacy, Nursing, Life Science, or related field
  • Associates/diploma degree with relevant work experience


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