Pharmacovigilance Coordinator Job at ProPharma Group, Wilmington, NC

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  • ProPharma Group
  • Wilmington, NC

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

Job Tags

Contract work, Local area, Remote job, Flexible hours,

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