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Pharmacovigilance Associate II

2 semanas atrás

São Paulo, São Paulo, Brasil Fortrea Tempo inteiro

Job Overview
We are seeking a detail-oriented and proactive Pharmacovigilance Associate II to support Clinical Trial and Post-Approval Case Processing Activities, primarily case follow-up activities. The primary responsibility of this role is to collect and process safety data through outreach to healthcare providers and consumers, ensuring compliance with regulatory requirements and internal procedures.

Summary Of Responsibilities

  • Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to:

  • Conduct outbound follow up requests to healthcare professionals and consumers to collect post-approval safety data. Outbound requests will be cascaded via email and fax requests.

  • Identify clinically significant information missing from the reports and ensure its collection and follow-up.
  • Review adverse event reports for completeness, accuracy, and expedited reporting requirements.
  • Data entry of safety data onto adverse event database(s) and tracking systems.

  • Ensure all cases that require expediting reporting to worldwide Regulatory Agencies and other required parties are processed swiftly and appropriately within required timelines.

  • Support additional activities such as data tracking, quality control, training, and data reconciliation.

  • Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
  • Support root cause analysis and CAPA plan development & implementation for identified quality issues as needed.
  • Support and/or participate in audits and inspections including the preparation as needed.
  • Demonstrate role-specific Core Competencies and company values on a consistent basis. Build and maintain good PSS relationships across functional units.
  • Undertake any other duties as needed.

Qualifications (Minimum Required)

  • Degree in one of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences
  • Associate's degree + 2 years of safety experience
  • BS/BA + 2 years of safety experience
  • MS/MA + 2 years of safety experience
  • PharmD + 2 years safety experience

Experience (Minimum Required)

  • Advanced command of English language, including speaking, writing, and reading.
  • Proven expertise in processing U.S. post-approval cases is mandatory
  • Proficient with the Argus safety database.
  • Strong typing ability and familiarity with Microsoft Office Suite and Windows environment is advantageous.
  • Strong attention to detail with a high degree of accuracy.
  • Ability to work independently with minimal supervision
  • Good understanding of ICH guidelines and global regulatory requirements for the reporting of adverse events for both marketed and investigational products.

Learn more about our EEO & Accommodations request here.