Job Description

Job Responsibilities

• Manages the US Patient Safety mailbox for AE reports and queries.
• Has a solid Pharmacovigilance Knowledge to understand and process the queries raised and delegate as appropriate.
• Individual in this role carries out a range of activities and processes to provide support to the US MC Patient Safety business unit that are both routine and very specific depending on the query.
• Perform all activities within the required timeframes to ensure compliance.
• Performs reconciliation to ensure cases reported through mailboxes have been processed in the system accurately.
• Performs reconciliation to ensure Licensing Partner cases have been processed in the system accurately.
• Provides postal mail management by uploading the scanned hardcopy mail into the system and reconciling.
• Conducts and/or supports pharmacovigilance activities on an individual basis working within established timeframes ensuring compliance with global and local procedures, policies, processes, and guidelines.

Skills and Requirements

• Life Sciences B.S. degree
• Basic competence with medical and therapeutic terminology.
• Able to work independently, guided by procedures, with appropriate support.
• Able to work effectively as part of a team.
• An understanding of the US FDA and international regulatory requirements for single case expedited reporting.
• Demonstrable communication skills.
• Maintains high ethical standards, including a commitment to AstraZeneca values and behaviors.
• Good attention to detail and quick learner.
• Good time management.
• Fluent in English.
• Tools: Experience using Microsoft Excel, Word, and Outlook

**1 year consulting opportunity; remote or hybrid schedule flexible

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