Pharmacovigilance Specialist

hace 2 meses


Ciudad de México, Ciudad de México IQVIA Argentina A tiempo completo

Job Overview

This role involves applying your knowledge and expertise to review, assess, and process Safety data across various service lines. You'll be recognized as a specialist in one or more areas, oversee small to medium operational projects, and mentor junior staff members.

Key Responsibilities

  1. Process Safety data as per regulations, guidelines, SOPs, and project requirements.
  2. Perform Pharmacovigilance activities, including collecting and tracking incoming Adverse Events (AE)/endpoint information, database entry, coding AE and Products, writing narratives, and more.
  3. Assess Safety data for reportability to relevant authorities and report within timelines.
  4. Contribute to or lead deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance, and Medical Information.
  5. Ensure quality, productivity, and delivery standards are met.
  6. Build a positive team environment, provide training and mentoring for less experienced team members.
  7. Provide technical and process information to Safety Management and operational team on project-specific issues.
  8. Maintain a thorough understanding of project protocol, therapeutic indication, budget, and scope of work (SOW) for assigned projects.
  9. Attend project team meetings and provide regular feedback/inputs to Operations team manager on operational project metrics, challenges, and successes.
  10. Contribute to the achievement of departmental goals.

Qualifications

  1. Bachelor's Degree in a scientific or healthcare discipline or allied life sciences.
  2. Up to 4 years of relevant experience, inclusive of up to 2 years of Pharmacovigilance experience.
  3. Excellent knowledge of medical terminology.
  4. In-depth knowledge and understanding of the applicable Safety Database and any other internal/Client applications.
  5. Excellent organizational skills, time management skills, attention to detail, and accuracy.
  6. Excellent working knowledge of Microsoft Office and web-based applications.
  7. Proven ability to work independently and autonomously with policies and practices.
  8. Ability to work effectively on multiple projects simultaneously, organize own workload, and effectively manage teams' priorities.
  9. Flexibility to operate in shifts.


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