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Pharmacovigilance Submissions Specialist

IQVIA

IQVIA

Buenos Aires, Argentina
Posted on Mar 14, 2025

Job Overview

Review, assess, and process safety data and information received from various sources. Distribute reports/data to internal and external third parties following applicable regulations, Standard Operating Procedures (SOPs), and internal guidelines under the guidance and support of senior operation team members.

Essential Functions

  • Process safety data according to applicable regulations, guidelines, SOPs, and project requirements.

  • Perform pharmacovigilance activities, including collecting and tracking incoming Adverse Events (AE)/endpoint information, determining initial/update status of incoming events, database entry, coding AE and products, writing narratives, and literature-related activities.

  • Ensure compliance with quality, productivity, and delivery standards per project requirements.

  • Create, maintain, and track cases as applicable to the project plan.

  • Identify and report quality problems to senior team members.

  • Liaise with different functional team members and health care professionals to address project-related issues.

  • Attend project team meetings and provide feedback to the operations manager on challenges, issues, or successes.

Qualifications

  • Bachelor's degree in life sciences

  • Advanced level of English

  • Regulatory Reporting & Submissions in pharmacovigilance and/or adverse events is highly valued

  • Good knowledge of medical terminology and applicable safety databases.

  • Strong organizational skills, attention to detail, and ability to work independently and as part of a team.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com