Senior Drug Safety Specialist
Drug Safety Specialist / Senior Specialist – Job Summary
We are looking for a Sr Drug Safety Specialist based in Brazil to work remote and support the triage and processing of Individual Case Safety Reports (ICSRs) from clinical trials and post‑marketing sources, ensuring timely and compliant submissions to global regulatory authorities.
Key Responsibilities
Process ICSRs, including case validation, day‑zero determination, review of source documents, and escalation of special safety situations.
Perform medical coding, narrative writing, listedness assessments, follow‑up determination, and Analysis of Similar Events.
Ensure workflow compliance by reviewing safety database timelines and case progression.
Conduct reconciliation between clinical trial databases and safety systems.
Execute due diligence activities, including query distribution and follow‑up with external reporters.
Contribute to compliance, productivity, and quality performance metrics.
Support continuous improvement initiatives and inspection readiness.
Make operational decisions aligned with SOPs, work instructions, and regulatory standards.
Required Knowledge & Experience
Understanding of global pharmacovigilance regulations (ICH, GVP, FDA, EMA, MHRA, NMPA, etc.).
Experience with safety databases and case processing (intake, triage, coding, narratives, due diligence).
Clinical knowledge of therapeutic areas and drug classes (preferred).
Strong time‑management skills and attention to detail.
Ability to collaborate with Safety Operations, Medical Review, Clinical Operations, Product Safety Leads, and other stakeholders.
Education & Experience Requirements
Bachelor’s degree in Life Sciences, Nursing, Pharmacy/PharmD, or other healthcare‑related field; equivalent education or professional experience accepted.
Advanced English (Mandatory) Advanced Spanish (preferred)
Minimum 1 year of experience in drug safety/pharmacovigilance or relevant clinical experience (training included).
Previous experience in the pharmaceutical industry preferred.
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.
Apply To This Job
We are looking for a Sr Drug Safety Specialist based in Brazil to work remote and support the triage and processing of Individual Case Safety Reports (ICSRs) from clinical trials and post‑marketing sources, ensuring timely and compliant submissions to global regulatory authorities.
Key Responsibilities
Process ICSRs, including case validation, day‑zero determination, review of source documents, and escalation of special safety situations.
Perform medical coding, narrative writing, listedness assessments, follow‑up determination, and Analysis of Similar Events.
Ensure workflow compliance by reviewing safety database timelines and case progression.
Conduct reconciliation between clinical trial databases and safety systems.
Execute due diligence activities, including query distribution and follow‑up with external reporters.
Contribute to compliance, productivity, and quality performance metrics.
Support continuous improvement initiatives and inspection readiness.
Make operational decisions aligned with SOPs, work instructions, and regulatory standards.
Required Knowledge & Experience
Understanding of global pharmacovigilance regulations (ICH, GVP, FDA, EMA, MHRA, NMPA, etc.).
Experience with safety databases and case processing (intake, triage, coding, narratives, due diligence).
Clinical knowledge of therapeutic areas and drug classes (preferred).
Strong time‑management skills and attention to detail.
Ability to collaborate with Safety Operations, Medical Review, Clinical Operations, Product Safety Leads, and other stakeholders.
Education & Experience Requirements
Bachelor’s degree in Life Sciences, Nursing, Pharmacy/PharmD, or other healthcare‑related field; equivalent education or professional experience accepted.
Advanced English (Mandatory) Advanced Spanish (preferred)
Minimum 1 year of experience in drug safety/pharmacovigilance or relevant clinical experience (training included).
Previous experience in the pharmaceutical industry preferred.
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.
Apply To This Job