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