Description
Summary:
This role involves reviewing, assessing, and processing safety data to ensure accurate case handling and timely report distribution while adhering to global regulations and project guidelines.
Highlights:
1. Process and triage safety data according to regulations and project requirements
2. Collaborate with cross-functional teams and healthcare professionals
3. Support onboarding and mentoring of new team members
Sao Paulo, Brazil \| Full time \| Home\-based \| R1528046**Job Overview**
----------------
The Operations Specialist \- Medical Information\- 100% remote will review, assess, and process safety data from multiple sources, ensuring accurate case handling and timely distribution of reports to internal and external stakeholders. All activities must follow global regulations, SOPs, and project‑specific guidelines, with support from senior team members.**Key Responsibilities**
------------------------
* Process and triage safety data according to regulations, SOPs, and project requirements.
* Collect, track, and assess incoming adverse events, determining initial vs. follow‑up status.
* Perform database entry, MedDRA coding, narrative writing, and literature surveillance.
* Maintain quality and productivity standards while ensuring full compliance with all procedures.
* Create, update, and track cases according to project plans.
* Identify and escalate quality issues to senior team members.
* Collaborate with cross‑functional teams (project management, clinical, data management) and healthcare professionals (investigators, medical monitors, site staff).
* Communicate with clients regarding day‑to‑day case processing when required.
* Support onboarding and mentoring of new team members when assigned.
* Participate in team meetings, audits, and inspections.
* Contribute to departmental initiatives and maintain 100% compliance with people processes.
* Depending on project needs, perform medical review of non‑serious AEs/ADRs, including coding checks, medical history review, concomitant medications, expectedness, causality assessment, and documentation.
**Required Qualifications**
---------------------------
* Bachelor’s degree in a scientific, healthcare, or life‑science field.
* Up to 3 years of experience in pharmacovigilance or equivalent training.
* Advanced English required.
* Strong knowledge of medical terminology and global safety regulations.
* Experience with safety databases and client/internal applications.
* Excellent attention to detail, accuracy, and quality standards.
* Proficiency in Microsoft Office and web‑based tools.
* Strong organizational and time‑management skills.
* Ability to work independently, follow guidelines, and manage multiple priorities.
* Strong teamwork skills and ability to build effective working relationships.
* Ability to work shifts and travel occasionally if required.
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
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.