Amgen Associate Product Safety in Istanbul, Turkey

  • 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