Associate Product Safety

Category: Safety
Job ID: R-68945
Employment Type: Full time
Location: Turkey – Istanbul
Posted Date: December 27, 2018
  • Manages adverse events.
  • Accurately evaluates cases for validity and consistency.
  • Documents cases according to procedures.
  • Accurately codes product-safety information and product-quality complaints.
  • Appropriately assesses case severity in order to prioritize follow-up.
  • Reviews data against source documents.
  • Submits data in a timely manner.
  • Properly assesses submission eligibility on a case-by-case basis as per the regulations.
  • Diligently prepares and checks required documentation.
  • Identifies appropriate regulatory agency directions and makes case referrals.
  • Carefully reviews and documents regulatory agency requests.
  • Prepares responses based on requests.
  • Prepares clear periodic reports.
  • Files case reports according to appropriate archiving practices.
  • Contributes to ensure compliance of pharmacovigilance activities:
  • Creates or adapts pharmacovigilance procedures based on overall or business-partner procedures and prevailing regulations.
  • Provides training to concerned persons based on the training plan.
  • Effectively manages training documentation.
  • Monitors pharmacovigilance procedures according to contracts, procedures, regulations, and directives.
  • Verifies data according to information sources prior to undertaking case reconciliation.
  • Properly reconciles cases and follows up on issues with concerned departments.
  • Plays an active role in the preparation, conduct, and monitoring of audits and inspections.
  • Archives documents according to prevailing standards.

    Qualifications

  • Graduation degree on pharmacy or medicine.

  • Result oriented personality with strong planning, reporting and analytical skills

  • Excellent command of English, both written and spoken

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