Safety Assessment Specialist
3 weeks ago
Job Summary
• Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays.
• Assess cases to distinguish those with particular complexities and/or specific issues, and escalate accordingly.
• Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, expectedness/listedness/labeledness); special scenarios; product complaint information; reportability with due date; and accuracy and consistency.
• Determine the appropriate workflow for case processing and develop reports ensuring adherence to regulatory compliance timelines.
• Liaise with key partners, including Pfizer Country Organizations, Clinical Development, License Partners, and other stakeholders regarding safety data collection and data reconciliation.
Requirements
• Experience in pharmacovigilance, in clinical care, or in clinical or scientific research is an advantage but not a requirement.
• Demonstrated computer literacy, particularly in the use and management of relational databases.
Preferred Qualifications
• Bachelor's degree in a science-related field, pharmacy, nursing, or equivalent; healthcare professional qualification preferred.
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